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Clinical Trial Results:
A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma

Summary
EudraCT number	2020-005708-20
Trial protocol	ES DE PT FR PL
Global end of trial date	02 Oct 2024

Results information
Results version number	v1(current)
This version publication date	23 Oct 2025
First version publication date	23 Oct 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GS-US-548-5916

ISRCTN number

US NCT number

NCT04854499

WHO universal trial number (UTN)

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

333 Lakeside Drive, Foster City, CA, United States, 94404

Public contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Scientific contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

02 Oct 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

02 Oct 2024

Was the trial ended prematurely?

Main objective of the trial

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).

Protection of trial subjects

The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki

Background therapy

Evidence for comparator

Actual start date of recruitment

07 Sep 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 19

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Germany: 7

Country: Number of subjects enrolled

Italy: 2

Country: Number of subjects enrolled

Poland: 29

Country: Number of subjects enrolled

Spain: 12

Country: Number of subjects enrolled

United Kingdom: 5

Country: Number of subjects enrolled

United States: 43

Country: Number of subjects enrolled

Portugal: 27

Worldwide total number of subjects

193

EEA total number of subjects

126

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

112

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

279 participants were screened.

Screening details

Participants were enrolled at study sites in Europe, North America and Asia Pacific. Optional Phase 2 Cohort 2 was never opened due to closure of the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum

Arm description

Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).

Arm type

Experimental

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

KEYTRUDA®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Magrolimab

Investigational medicinal product code

Other name

GS-4721

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

5-FU

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU

Arm description

Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.

Arm type

Experimental

Investigational medicinal product name

Magrolimab

Investigational medicinal product code

Other name

GS-4721

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

KEYTRUDA®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

5-FU

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Arm description

Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.

Arm type

Experimental

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

KEYTRUDA®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

5-FU

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU

Arm description

Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Day 1; 30 mg/kg on Days 8 and 15 of Cycles 1 and 2 and On Day 1 of Cycle 2; 60 mg mg/kg on Day 1 of Cycle 3 for 21-day cycle each for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of Cycle 1, 2 and 3 for 21-day cycle each for up to 40 weeks; 5-FU 1000 mg/m^2/day continuous IV on Days 1 to 4 of Cycle 1, 2 and 3 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycle 1, 2 and 3 to 6 for 21-day cycle each for up to 16 weeks.

Arm type

Experimental

Investigational medicinal product name

Magrolimab

Investigational medicinal product code

Other name

GS-4721

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Zimberelimab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

5-FU

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Safety Run-in Cohort 2: Magrolimab + Docetaxel

Arm description

Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.

Arm type

Experimental

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Magrolimab

Investigational medicinal product code

Other name

GS-4721

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Phase 2 Cohort 3: Magrolimab + Docetaxel

Arm description

Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.

Arm type

Experimental

Investigational medicinal product name

Magrolimab

Investigational medicinal product code

Other name

GS-4721

Pharmaceutical forms

Suspension for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered intravenously

Number of subjects in period 1 ^[1]	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 3: Magrolimab + Docetaxel
Started	6	52	54	32	7	41
Completed	0	0	0	0	0	0
Not completed	6	52	54	32	7	41
Death	1	23	21	7	6	24
Study terminated by sponsor	5	27	28	19	1	10
Investigator's discretion	-	1	3	4	-	5
Withdrew consent	-	1	2	2	-	1
Lost to follow-up	-	-	-	-	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 1 participant who was randomized but not treated was not included in the Modified Intent-to-Treat (mITT) Analysis Set in Safety Run-In 2 Cohort for Period 1 table reported above.

Baseline characteristics

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Reporting group title

Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum

Reporting group description

Reporting group title

Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU

Reporting group description

Reporting group title

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Reporting group description

Reporting group title

Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU

Reporting group description

Reporting group title

Safety Run-in Cohort 2: Magrolimab + Docetaxel

Reporting group description

Reporting group title

Phase 2 Cohort 3: Magrolimab + Docetaxel

Reporting group description

Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.

Reporting group values	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 3: Magrolimab + Docetaxel	Total
Number of subjects	6	52	54	32	7	41	192
Age categorical
Units: Subjects
< 65	1	35	33	16	5	22	112
>= 65	5	17	21	16	2	19	80
Age continuous
Units: years
arithmetic mean (standard deviation)	69 ( 6.2 )	61 ( 7.4 )	61 ( 9.5 )	63 ( 11.4 )	58 ( 15.5 )	63 ( 9.9 )	-
Gender categorical
Units: Subjects
Female	0	9	11	5	0	4	29
Male	6	43	43	27	7	37	163
Race
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	1	0	1	0	0	2	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0
White	5	44	47	26	6	30	158
More than one race	0	6	5	5	0	7	30
Ethnicity
Units: Subjects
Hispanic or Latino	0	2	0	3	1	1	7
Not Hispanic or Latino	6	43	44	22	6	32	153
Unknown or Not Reported	0	7	10	7	0	8	32

End points

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Reporting group title

Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum

Reporting group description

Reporting group title

Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU

Reporting group description

Reporting group title

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Reporting group description

Reporting group title

Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU

Reporting group description

Reporting group title

Safety Run-in Cohort 2: Magrolimab + Docetaxel

Reporting group description

Reporting group title

Phase 2 Cohort 3: Magrolimab + Docetaxel

Reporting group description

Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

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End point title

Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ^[1] ^[2]

End point description

A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the AE was related to magrolimab and the relationship of the AE with the combination partner regimen can be ruled out. DLT Evaluable Analysis Set was defined as all participants in the safety run-in evaluations who meet either of the following criteria during the DLT assessment period: - The participants experienced a DLT at any time after initiation of the first infusion of magrolimab. - The participant did not experience a DLT and completed at least 2 infusions of magrolimab and at least 1 dose of pembrolizumab, platinum, and 5-FU for Safety Run-in 1 Cohort 1; at least 1 dose of docetaxel for Safety Run-in Cohort 2.

End point type

Primary

End point timeframe

First dose date up to 21 days

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Safety Run-In Arms 1 and 2. Hence the data is not reported for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C for this endpoint.

End point values	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Safety Run-in Cohort 2: Magrolimab + Docetaxel
Number of subjects analysed	6	6
Units: percentage of participants
number (not applicable)	0	0

No statistical analyses for this end point

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Laboratory Abnormalities According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

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End point title

Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Laboratory Abnormalities According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ^[3] ^[4]

End point description

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point up to and including last dose date of study drug plus 30 days (or last dose date of zimberelimab plus 90 days) and prior to the day of initiation of subsequent anti-cancer therapy. Analysis Population Description : Safety Run-in Cohorts 1 and 2: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

End point type

Primary

End point timeframe

First dose date up to 73 weeks plus 30 days

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Safety Run-In Arms 1 and 2. Hence the data is not reported for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C for this endpoint.

End point values	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Safety Run-in Cohort 2: Magrolimab + Docetaxel
Number of subjects analysed	6	7
Units: percentage of participants
number (not applicable)	83.3	71.4

No statistical analyses for this end point

Primary: Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)

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End point title

Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS) ^[5]

End point description

PFS was defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis. Participants in Phase 2 Cohort 1, Arms A and B in the ITT analysis set were analyzed.

End point type

Primary

End point timeframe

Up to 129 weeks

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 cohort Arms A and B. Hence the data is not reported for Phase 2 Cohort 3 and Phase 2 cohort Arm C for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU
Number of subjects analysed	52	54
Units: months
median (confidence interval 95%)	5.5 (3.0 to 6.9)	5.6 (4.2 to 7.4)

Phase 2 Cohort 1 Arm A Vs Arm B

Comparison groups

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU v Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.314

Confidence interval

level

95%

sides

2-sided

lower limit

0.809

upper limit

2.136

Primary: Phase 2 Cohort 3: Objective Response Rate (ORR)

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End point title

Phase 2 Cohort 3: Objective Response Rate (ORR) ^[6] ^[7]

End point description

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by investigator assessment. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants in Phase 2 Cohort 3 in the mITT Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Up to 129 weeks

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3. Hence the data for Phase 2 cohort Arms A, B and C is not reported for this endpoint.

End point values	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	41
Units: percentage of participants
number (confidence interval 95%)	12.2 (4.1 to 26.2)

No statistical analyses for this end point

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab

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End point title

Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab ^[8]

End point description

Participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set, defined as all participants who received any amount of magrolimab and have at least 1 evaluable post-treatment serum concentration of magrolimab, at the given timepoint were analyzed. 999: Data is not available as the concentrations were below the level of quantification.

End point type

Secondary

End point timeframe

Day 8 1-Hour Postdose; Days 15, 22, 43: Predose; Day 43 1-Hour Postdose; Day 71 1-Hour Postdose; Days 85,127, 190,197, 211, 253 Predose; Day 253 1-Hour Postdose

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3, Phase 2 Cohort 1 Arm A and Safety Run-in Arms 1 and 2. Hence the data is not reported for Phase 2 Cohort 1 Arm C for this endpoint.

End point values	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	6	41	6	29
Units: μg/mL
arithmetic mean (standard deviation)
D 8 1 HourPostdose N=5,15,5,5	305 ( 56.4 )	481 ( 137 )	288 ( 55.2 )	459 ( 140 )
D 15 Predose N=0,24,0,16	999 ( 0 )	149 ( 52.8 )	999 ( 0 )	125 ( 49.4 )
D 22 Predose N=6,41,6,29	208 ( 185 )	250 ( 100 )	255 ( 149 )	253 ( 110 )
D 43 Predose N=5,38,5,27	359 ( 253 )	397 ( 195 )	561 ( 514 )	477 ( 219 )
D 43 1-Hour Postdose N=0,24,0,19	999 ( 0 )	1440 ( 306 )	999 ( 0 )	1330 ( 426 )
D 71 1-Hour Postdose N=0,0,0,1	999 ( 0 )	999 ( 0 )	999 ( 0 )	572 ( 0 )
D 85 Predose N=4,31,2,18	138 ( 106 )	308 ( 140 )	813 ( 830 )	272 ( 119 )
D 127 Predose N=3,4,0,1	142 ( 113 )	204 ( 235 )	999 ( 0 )	393 ( 0 )
D 190 Predose N=1,12,1,4	707 ( 0 )	359 ( 94.9 )	999 ( 0 )	270 ( 95.9 )
D 211 Predose N=0,0,1,0	999 ( 0 )	74.8 ( 0 )	999 ( 0 )	999 ( 0 )
D 253 Predose N=1,1,0,0	543 ( 0 )	252 ( 0 )	999 ( 0 )	999 ( 0 )
D 253 1-Hour Postdose N=0,1,0,0	999 ( 0 )	228 ( 0 )	999 ( 0 )	999 ( 0 )

No statistical analyses for this end point

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab

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End point title

Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab

End point description

Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.

End point type

Secondary

End point timeframe

Up to end of treatment (up to approximately 73 weeks)

End point values	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	6	41	0 ^[9]	32	7	40
Units: percentage of participants
number (not applicable)
ADA Prevalence	16.7	3.8		0	0	5.0
ADA Incidence	0	0		3.1	0	3.1

Notes
[9] - No participants were analyzed from this group.

No statistical analyses for this end point

Secondary: Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)

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End point title

Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS) ^[10]

End point description

PFS was defined as the time from the date of randomization (Phase 2 Cohorts 1) or date of dose initiation (Phase 2 Cohorts 2 and 3) until the earliest date of documented disease progression as determined by investigator assessment per RECIST, version 1.1, or death from any cause, whichever occurs first. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis. Participants in Phase 2 Cohort 1 Arms B and C in the ITT Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Up to 129 weeks

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort Arms B and C. Hence the data is not reported for Phase 2 Cohort 3 and Phase 2 cohort Arm A for this endpoint.

End point values	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU
Number of subjects analysed	54	32
Units: months
median (confidence interval 95%)	5.6 (4.2 to 7.4)	5.5 (3.0 to 9.2)

Phase 2 Cohort 1 Arm B Vs Arm C

Comparison groups

Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU v Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.094

Confidence interval

level

95%

sides

2-sided

lower limit

0.603

upper limit

1.985

Secondary: Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)

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End point title

Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR) ^[11]

End point description

ORR was defined as the percentage of participants who achieved a CR or PR as determined by investigator assessment. CR and PR are defined in OM#3. Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Up to 129 weeks

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 cohort Arms A, B and C. Hence the data for Arm Phase 2 Cohort 3 is not reported for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU
Number of subjects analysed	52	54	32
Units: percentage of participants
number (confidence interval 95%)	38.5 (25.3 to 53.0)	38.9 (25.9 to 53.1)	37.5 (21.1 to 56.3)

Phase 2 Cohort 1 Arm B Vs Phase 2 Cohort 1 Arm C

Comparison groups

Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU v Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

0.943

Confidence interval

level

95%

sides

2-sided

lower limit

0.383

upper limit

2.321

Ph 2 Cohort 1 Arm A Vs Ph 2 Cohort 1 Arm B

Comparison groups

Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU v Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

0.982

Confidence interval

level

95%

sides

2-sided

lower limit

0.449

upper limit

2.147

Secondary: Phase 2 Cohort 3: Progression-free Survival (PFS)

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End point title

Phase 2 Cohort 3: Progression-free Survival (PFS) ^[12]

End point description

PFS was defined as the time from the date of dose initiation (Phase 2 Cohort 3) until the earliest date of documented disease progression as determined by investigator assessment per RECIST, version 1.1, or death from any cause, whichever occurs first. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis. Participants in Phase 2 Cohort 3 in the mITT Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Up to 129 weeks

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3. Hence the data for Phase 2 cohort Arms A, B and C is not reported for this endpoint.

End point values	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	41
Units: months
median (confidence interval 95%)	3.6 (2.4 to 4.8)

No statistical analyses for this end point

Secondary: All Phase 2 Cohorts: Duration of Response (DOR)

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End point title

All Phase 2 Cohorts: Duration of Response (DOR) ^[13]

End point description

DOR was defined as the time from first documentation of CR or PR to the earliest date of documented disease progression or death from any cause, whichever occurs first. Disease progression is defined in OM#2 and CR and PR are defined in OM#3.Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT and participants in Phase 2 Cohort 3 in the mITT analysis set who achieved overall response were analyzed. 9999: Upper limit of Confidence interval (CI) was not estimable due to low number of participants with events.

End point type

Secondary

End point timeframe

Up to 129 weeks

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	20	21	12	5
Units: months
median (confidence interval 95%)	5.4 (3.5 to 9.3)	6.2 (3.6 to 9999)	6.3 (2.8 to 9999)	5.0 (3.3 to 9999)

No statistical analyses for this end point

Secondary: All Phase 2 Cohorts: Overall Survival (OS)

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End point title

All Phase 2 Cohorts: Overall Survival (OS) ^[14]

End point description

OS was defined as the time from the date of randomization (Phase 2 Cohorts 1) or time from the date of dose initiation (Phase 2) to death from any cause. KM estimates were used in outcome measure analysis. Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT and participants in Phase 2 Cohort 3 in the mITT analysis set were analyzed.

End point type

Secondary

End point timeframe

Up to 129 weeks

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	52	54	32	41
Units: months
median (confidence interval 95%)	10.8 (6.9 to 18.2)	13.3 (9.1 to 9999)	9999 (7.9 to 9999)	9.1 (6.6 to 12.7)

No statistical analyses for this end point

Secondary: Phase 2 Cohorts: Change from Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score

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End point title

Phase 2 Cohorts: Change from Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score ^[15]

End point description

EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicated a higher level of symptoms (i.e. a worse state of the participant). Phase 2 Cohort 1: Participants in the Intent to Treat Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in mITT Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	52	50	28	37
Units: score on scale
arithmetic mean (standard deviation)
GlobalHealthStatus(GHS)/QoL,Baseline N=51,50,28,37	54.7 ( 24.9 )	57.3 ( 23.2 )	55.1 ( 20.8 )	55.4 ( 25.6 )
CFB in GHS/QoL, Week 3 N=42,43,23,29	5.0 ( 20.2 )	1.9 ( 23.3 )	-3.6 ( 16.1 )	1.7 ( 18.1 )
CFB in GHS/QoL, Week 6 N=32,36,16,26	6.0 ( 26.5 )	10.2 ( 26.7 )	-1.0 ( 16.9 )	-1.3 ( 23.7 )
CFB in GHS/QoL, Week 9 N=27,30,18,21	2.8 ( 22.2 )	1.1 ( 27.6 )	-4.2 ( 18.6 )	2.0 ( 19.0 )
CFB in GHS/QoL, Week 12 N=31,34,17,18	-4.8 ( 29.2 )	6.4 ( 25.8 )	2.9 ( 14.1 )	-4.2 ( 20.5 )
CFB in GHS/QoL, Week 15 N=30,29,13,18	-0.3 ( 27.0 )	5.2 ( 25.8 )	2.6 ( 22.7 )	0.0 ( 24.8 )
CFB in GHS/QoL, Week 18 N=28,25,11,15	5.4 ( 27.0 )	10.0 ( 26.4 )	-4.5 ( 23.1 )	-2.8 ( 23.7 )
CFB in GHS/QoL, Week 21 N=23,24,10,13	4.3 ( 28.1 )	4.9 ( 22.4 )	-10.8 ( 23.6 )	-8.3 ( 20.7 )
CFB in GHS/QoL, Week 24 N=20,18,12,9	9.2 ( 26.3 )	1.9 ( 20.9 )	-5.6 ( 23.9 )	-10.2 ( 15.5 )
CFB in GHS/QoL, Week 27 N=15,15,6,5	2.2 ( 27.7 )	0.0 ( 18.6 )	6.9 ( 26.0 )	1.7 ( 24.6 )
CFB in GHS/QoL, Week 90 N=1,0,0,0	33.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Physical Functioning(PF), Baseline N=52,50,27,37	75.0 ( 25.3 )	75.4 ( 23.2 )	74.9 ( 23.2 )	73.7 ( 23.8 )
CFB in PF, Week 3 N=43,43,22,29	-4.8 ( 15.6 )	-3.6 ( 21.2 )	-9.2 ( 15.7 )	-2.9 ( 17.0 )
CFB in PF, Week 6 N=33,36,15,27	-3.4 ( 14.4 )	2.2 ( 20.2 )	-6.2 ( 15.6 )	-11.3 ( 21.7 )
CFB in PF, Week 9 N=28,30,18,21	-1.4 ( 21.3 )	-1.0 ( 18.8 )	-4.3 ( 15.9 )	-2.9 ( 13.9 )
CFB in PF, Week 12 N=32,34,16,18	-4.5 ( 22.7 )	3.8 ( 23.7 )	-5.3 ( 15.7 )	-10.0 ( 17.5 )
CFB in PF, Week 15 N=31,29,12,18	-6.5 ( 21.0 )	3.3 ( 26.2 )	-13.3 ( 24.1 )	-11.9 ( 19.7 )
CFB in PF, Week 18 N=29,26,10,15	0.0 ( 15.5 )	2.7 ( 27.7 )	-4.7 ( 13.4 )	-16.0 ( 20.7 )
CFB in PF, Week 21 N=24,24,11,13	-5.0 ( 20.9 )	-6.5 ( 21.4 )	-12.1 ( 19.3 )	-21.0 ( 24.2 )
CFB in PF, Week 24 N=21,17,12,9	-5.1 ( 15.9 )	-7.4 ( 23.6 )	-8.3 ( 14.0 )	-21.5 ( 10.9 )
CFB in PF, Week 27 N=16,15,5,5	-7.9 ( 17.6 )	0.0 ( 20.3 )	-12.0 ( 14.5 )	-22.7 ( 18.0 )
CFB in PF, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Role Functioning (RF), Baseline N=52,49,27,37	72.8 ( 32.5 )	74.5 ( 27.7 )	69.8 ( 32.0 )	60.8 ( 35.4 )
CFB in RF, Week 3 N=43,41,22,29	-1.9 ( 21.6 )	-2.4 ( 33.9 )	-12.1 ( 37.2 )	-5.7 ( 28.3 )
CFB in RF, Week 6 N=33,35,15,26	-5.1 ( 23.4 )	2.4 ( 32.6 )	-10.0 ( 19.7 )	-3.2 ( 26.7 )
CFB in RF, Week 9 N=28,30,18,21	-3.6 ( 29.2 )	-5.6 ( 35.1 )	-9.3 ( 30.4 )	7.9 ( 27.2 )
CFB in RF, Week 12 N=32,34,16,18	-6.2 ( 35.9 )	2.0 ( 38.0 )	-7.3 ( 33.3 )	-8.3 ( 37.6 )
CFB in RF, Week 15 N=32,29,12,18	-10.4 ( 36.4 )	7.5 ( 35.8 )	-6.9 ( 28.8 )	-4.6 ( 32.2 )
CFB in RF, Week 18 N=29,26,10,15	-4.0 ( 30.7 )	-1.3 ( 37.1 )	-5.0 ( 19.3 )	-7.8 ( 37.2 )
CFB in RF, Week 21 N=24,23,11,13	-6.9 ( 38.0 )	-11.6 ( 29.1 )	-13.6 ( 35.6 )	-14.1 ( 39.0 )
CFB in RF, Week 24 N=21,18,12,9	-4.8 ( 32.6 )	-2.8 ( 30.9 )	0.0 ( 24.6 )	-20.4 ( 21.7 )
CFB in RF, Week 27 N=16,15,5,5	-16.7 ( 21.1 )	-11.1 ( 37.1 )	-10.0 ( 22.4 )	-23.3 ( 19.0 )
CFB in RF, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Emotional Functioning (EF), Baseline N=51,50,28,37	69.5 ( 25.3 )	69.7 ( 27.6 )	70.3 ( 28.3 )	81.5 ( 16.4 )
CFB in EF, Week 3 N=42,43,23,29	7.7 ( 25.1 )	7.5 ( 25.2 )	5.7 ( 20.9 )	1.2 ( 17.5 )
CFB in EF, Week 6 N=32,36,16,26	12.6 ( 23.5 )	12.3 ( 25.9 )	4.0 ( 24.6 )	-5.7 ( 21.8 )
CFB in EF, Week 9 N=27,30,18,21	7.7 ( 19.8 )	6.1 ( 16.5 )	11.4 ( 22.6 )	0.1 ( 14.8 )
CFB in EF, Week 12 N=31,34,17,18	3.8 ( 24.6 )	11.8 ( 20.7 )	9.6 ( 21.0 )	1.5 ( 11.6 )
CFB in EF, Week 15 N=30,29,13,18	0.3 ( 28.0 )	11.8 ( 27.1 )	3.6 ( 19.8 )	-5.4 ( 19.3 )
CFB in EF, Week 18 N=28,25,11,15	3.7 ( 23.8 )	12.0 ( 25.8 )	6.6 ( 28.6 )	-4.4 ( 16.5 )
CFB in EF, Week 21 N=23,24,10,13	0.8 ( 22.6 )	2.0 ( 22.5 )	6.7 ( 12.3 )	-5.6 ( 12.7 )
CFB in EF, Week 24 N=20,18,13,9	3.1 ( 20.0 )	4.6 ( 22.4 )	2.4 ( 19.8 )	-4.3 ( 9.0 )
CFB in EF, Week 27 N=15,15,6,5	0.6 ( 16.5 )	9.6 ( 10.9 )	6.5 ( 27.6 )	-11.1 ( 18.1 )
CFB in EF, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Cognitive Functioning (CF)BaselineN=51,50,28,37	84.0 ( 22.1 )	84.7 ( 22.3 )	85.7 ( 16.8 )	83.8 ( 21.3 )
CFB in CF, Week3 N=42,43,23,29	1.6 ( 16.0 )	-0.4 ( 20.7 )	-7.2 ( 14.1 )	-4.6 ( 16.6 )
CFB in CF, Week6 N=32,36,16,26	2.1 ( 15.7 )	0.9 ( 25.8 )	-1.0 ( 7.4 )	-2.6 ( 24.4 )
CFB in CF, Week9 N=27,30,18,21	1.9 ( 14.1 )	-0.6 ( 14.8 )	-2.8 ( 13.1 )	-4.8 ( 19.1 )
CFB in CF, Week12 N=31,34,17,18	-6.5 ( 23.8 )	1.5 ( 18.5 )	-4.9 ( 12.9 )	-3.7 ( 20.3 )
CFB in CF, Week15 N=31,29,13,18	-3.8 ( 22.2 )	0.6 ( 19.1 )	-1.3 ( 12.7 )	-1.9 ( 13.9 )
CFB in CF, Week18 N=28,25,11,15	-4.8 ( 22.2 )	-1.3 ( 20.9 )	-6.1 ( 8.4 )	-3.3 ( 16.9 )
CFB in CF, Week21 N=23,24,10,13	-3.6 ( 20.1 )	-0.7 ( 18.7 )	-6.7 ( 8.6 )	-10.3 ( 26.8 )
CFB in CF, Week24 N=20,18,13,9	-3.3 ( 16.8 )	-3.7 ( 18.6 )	-3.8 ( 12.1 )	-13.0 ( 16.2 )
CFB in CF, Week27 N=15,15,6,5	0.0 ( 15.4 )	-4.4 ( 11.7 )	-5.6 ( 8.6 )	-33.3 ( 31.2 )
CFB in CF, Week90 N=1,0,0,0	16.7 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Social Functioning(SF), Baseline N=51,49,28,37	75.5 ( 26.5 )	73.8 ( 31.2 )	76.8 ( 24.1 )	68.0 ( 36.9 )
CFB in SF, Week 3 N=42,43,23,29	2.4 ( 24.6 )	-3.5 ( 33.6 )	-12.3 ( 23.7 )	-3.4 ( 30.3 )
CFB in SF, Week 6 N=32,36,16,26	3.6 ( 27.7 )	6.9 ( 33.4 )	-7.3 ( 18.2 )	1.3 ( 35.6 )
CFB in SF, Week 9 N=27,30,18,21	-3.7 ( 28.6 )	-3.3 ( 23.3 )	-7.4 ( 21.6 )	9.5 ( 34.0 )
CFB in SF, Week 12 N=31,33,17,18	-2.2 ( 30.0 )	0.5 ( 31.0 )	-4.9 ( 19.3 )	-7.4 ( 27.5 )
CFB in SF, Week 15 N=31,29,13,18	-8.1 ( 34.1 )	4.0 ( 27.7 )	5.1 ( 23.0 )	-2.8 ( 41.3 )
CFB in SF, Week 18 N=28,25,11,15	1.2 ( 22.6 )	2.7 ( 19.6 )	-1.5 ( 15.7 )	7.8 ( 36.1 )
CFB in SF, Week 21 N=23,24,10,13	-5.8 ( 30.0 )	-0.7 ( 24.3 )	-11.7 ( 28.4 )	-5.1 ( 41.6 )
CFB in SF, Week 24 N=20,18,13,9	-0.8 ( 28.9 )	-4.6 ( 32.7 )	-1.3 ( 22.0 )	-22.2 ( 25.0 )
CFB in SF, Week 27 N=15,15,6,5	-2.2 ( 30.8 )	-5.6 ( 12.1 )	-5.6 ( 13.6 )	-33.3 ( 31.2 )
CFB in SF, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Fatigue, Baseline N=52,50,28,37	37.4 ( 28.9 )	38.6 ( 24.3 )	40.1 ( 30.3 )	42.9 ( 29.9 )
CFB in Fatigue, Week 3 N=43,43,23,29	1.7 ( 19.7 )	2.5 ( 20.8 )	7.2 ( 26.7 )	8.0 ( 25.7 )
CFB in Fatigue, Week 6 N=33,36,16,27	-2.7 ( 21.9 )	-5.4 ( 27.3 )	4.2 ( 27.5 )	13.2 ( 28.9 )
CFB in Fatigue, Week 9 N=28,30,19,21	0.4 ( 22.5 )	-0.2 ( 31.2 )	3.8 ( 29.5 )	-3.2 ( 26.8 )
CFB in Fatigue, Week 12 N=32,34,17,18	2.8 ( 24.1 )	-4.4 ( 26.9 )	2.0 ( 26.1 )	8.6 ( 27.4 )
CFB in Fatigue, Week 15 N=31,29,13,18	8.6 ( 28.4 )	-4.4 ( 27.5 )	8.5 ( 36.6 )	12.3 ( 24.7 )
CFB in Fatigue, Week 18 N=29,26,11,15	4.2 ( 23.8 )	-2.6 ( 25.5 )	7.1 ( 36.6 )	18.5 ( 31.6 )
CFB in Fatigue, Week 21 N=24,24,12,13	3.7 ( 27.3 )	2.5 ( 23.9 )	11.6 ( 40.2 )	15.4 ( 30.6 )
CFB in Fatigue, Week 24 N=21,18,13,9	4.8 ( 22.4 )	0.9 ( 24.9 )	7.7 ( 29.9 )	29.6 ( 15.7 )
CFB in Fatigue, Week 27 N=16,15,5,5	2.1 ( 17.8 )	4.8 ( 27.8 )	2.2 ( 25.3 )	35.6 ( 24.1 )
CFB in Fatigue, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Nausea-Vomiting, Baseline N=51,50,28,37	5.6 ( 16.6 )	5.7 ( 12.4 )	4.8 ( 11.9 )	7.7 ( 15.5 )
CFB in Nausea-Vomiting, Week3 N=42,43,23,29	6.7 ( 20.2 )	5.0 ( 16.5 )	15.9 ( 34.3 )	2.9 ( 12.7 )
CFB in Nausea-Vomiting, Week6 N=33,36,16,27	1.0 ( 13.8 )	2.3 ( 21.1 )	2.1 ( 16.0 )	0.6 ( 16.3 )
CFB in Nausea-Vomiting, Week9 N=27,30,19,21	8.6 ( 25.1 )	3.9 ( 20.4 )	7.9 ( 25.1 )	5.6 ( 21.3 )
CFB in Nausea-Vomiting, Week12N=30,34,17,18	13.3 ( 27.5 )	3.9 ( 18.8 )	1.0 ( 23.9 )	-1.9 ( 13.9 )
CFB in Nausea-Vomiting, Week15N=31,29,13,18	5.9 ( 21.8 )	5.7 ( 22.8 )	5.1 ( 12.5 )	3.7 ( 18.6 )
CFB in Nausea-Vomiting, Week18N=28,26,11,15	3.6 ( 18.9 )	4.5 ( 21.9 )	3.0 ( 10.1 )	5.6 ( 26.5 )
CFB in Nausea-Vomiting, Week21N=24,24,12,13	7.6 ( 18.4 )	6.3 ( 21.3 )	11.1 ( 29.6 )	7.7 ( 20.0 )
CFB in Nausea-Vomiting, Week24N=21,18,13,9	4.8 ( 12.0 )	0.0 ( 9.9 )	5.1 ( 12.5 )	-1.9 ( 13.0 )
CFB in Nausea-Vomiting, Week27N=6,15,5,5	2.1 ( 12.0 )	4.4 ( 13.3 )	13.3 ( 18.3 )	-3.3 ( 18.3 )
CFB in Nausea-Vomiting, Week90N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Pain,Baseline N=52,50,28,37	37.2 ( 32.1 )	40.3 ( 30.9 )	39.9 ( 31.5 )	36.0 ( 33.2 )
CFB in Pain, Week3 N=43,43,23,29	-5.8 ( 27.4 )	-3.9 ( 31.0 )	-2.9 ( 25.5 )	-5.7 ( 27.9 )
CFB in Pain, Week6 N=33,36,16,27	-12.1 ( 22.5 )	-19.9 ( 36.0 )	-10.4 ( 22.7 )	-3.7 ( 34.1 )
CFB in Pain, Week9 N=28,30,19,21	-7.7 ( 23.8 )	-13.9 ( 29.1 )	-8.8 ( 28.5 )	-13.5 ( 28.2 )
CFB in Pain, Week 12 N=32,34,17,18	-4.7 ( 28.5 )	-23.0 ( 34.6 )	-13.7 ( 24.5 )	-3.7 ( 31.6 )
CFB in Pain, Week 15 N=32,29,13,18	-2.6 ( 31.4 )	-19.0 ( 36.4 )	0.0 ( 30.4 )	-4.6 ( 34.2 )
CFB in Pain, Week 18 N=29,26,11,15	-8.0 ( 22.5 )	-18.6 ( 35.4 )	6.1 ( 15.4 )	-2.2 ( 30.8 )
CFB in Pain, Week 21 N=24,24,12,13	-1.4 ( 28.6 )	-10.4 ( 31.8 )	-1.4 ( 35.9 )	-6.4 ( 35.7 )
CFB in Pain, Week24 N=21,18,13,9	-0.8 ( 22.0 )	-12.0 ( 29.6 )	0.0 ( 31.2 )	9.3 ( 16.9 )
CFB in Pain, Week 27 N=16,15,6,5	9.4 ( 28.5 )	-8.9 ( 39.3 )	8.3 ( 17.5 )	16.7 ( 39.1 )
CFB in Pain, Week 90 N=1,0,0,0	-16.7 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Dyspnoea,Baseline N=51,50,28,37	17.0 ( 25.3 )	15.3 ( 24.5 )	22.6 ( 31.5 )	24.3 ( 32.1 )
CFB in Dyspnoea,Week 3 N=42,43,23,29	0.8 ( 20.1 )	2.3 ( 28.5 )	1.4 ( 18.7 )	9.2 ( 23.4 )
CFB in Dyspnoea,Week 6 N=32,35,16,27	2.1 ( 20.6 )	-1.9 ( 27.9 )	6.3 ( 18.1 )	13.6 ( 34.9 )
CFB in Dyspnoea,Week 9 N=28,30,19,21	0.0 ( 22.2 )	10.0 ( 34.1 )	-5.3 ( 20.1 )	11.1 ( 21.9 )
CFB in Dyspnoea,Week12 N=32,34,17,18	3.1 ( 23.0 )	5.9 ( 32.3 )	3.9 ( 20.0 )	0.0 ( 19.8 )
CFB in Dyspnoea,Week15 N=31,29,13,18	10.8 ( 29.0 )	3.4 ( 32.5 )	5.1 ( 26.7 )	13.0 ( 25.9 )
CFB in Dyspnoea,Week18 N=29,26,11,15	4.6 ( 21.3 )	7.7 ( 30.3 )	9.1 ( 15.6 )	24.4 ( 29.5 )
CFB in Dyspnoea,Week21 N=24,24,12,13	5.6 ( 21.2 )	16.7 ( 32.6 )	11.1 ( 35.8 )	20.5 ( 29.0 )
CFB in Dyspnoea,Week 24 N=21,18,13,9	1.6 ( 22.3 )	5.6 ( 32.8 )	7.7 ( 24.2 )	11.1 ( 28.9 )
CFB in Dyspnoea,Week 27 N=16,15,5,5	2.1 ( 14.8 )	4.4 ( 24.8 )	6.7 ( 14.9 )	13.3 ( 38.0 )
CFB in Dyspnoea,Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Symptom Scales Insomnia: Baseline N=52,50,28,37	39.1 ( 27.0 )	34.7 ( 30.1 )	34.5 ( 35.7 )	34.2 ( 33.8 )
CFB in Insomnia,Week 3 N=43,43,23,29	-17.8 ( 26.6 )	0.0 ( 32.5 )	2.9 ( 26.4 )	-2.3 ( 23.5 )
CFB in Insomnia,Week 6 N=33,36,16,26	-15.2 ( 31.3 )	-11.1 ( 39.0 )	14.6 ( 32.1 )	1.3 ( 31.9 )
CFB in Insomnia,Week 9 N=28,30,19,21	-11.9 ( 35.4 )	-20.0 ( 38.8 )	-8.8 ( 21.8 )	-9.5 ( 23.9 )
CFB in Insomnia,Week 12 N=32,34,17,18	-15.6 ( 40.6 )	-16.7 ( 34.1 )	-7.8 ( 30.1 )	-3.7 ( 25.3 )
CFB in Insomnia,Week 15 N=31,29,13,18	-11.8 ( 36.1 )	-13.8 ( 33.9 )	-5.1 ( 23.0 )	-7.4 ( 31.4 )
CFB in Insomnia,Week 18 N=29,26,11,15	-11.5 ( 27.1 )	-7.7 ( 40.3 )	-3.0 ( 37.9 )	6.7 ( 28.7 )
CFB in Insomnia,Week 21 N=24,24,12,13	-2.8 ( 27.7 )	-6.9 ( 42.8 )	-2.8 ( 17.2 )	-2.6 ( 41.9 )
CFB in Insomnia,Week 24 N=21,18,13,9	-4.8 ( 30.3 )	-11.1 ( 37.9 )	-10.3 ( 34.4 )	11.1 ( 33.3 )
CFB in Insomnia,Week N=16,15,5,5	0.0 ( 36.5 )	2.2 ( 44.5 )	6.7 ( 27.9 )	13.3 ( 50.6 )
CFB in Insomnia,Week90 N=1,0,0,0	-33.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Appetite Loss,Baseline N=52,50,27,36	29.5 ( 37.7 )	20.7 ( 24.2 )	29.6 ( 31.1 )	32.4 ( 36.1 )
CFB in Apettite Loss,Week 3N=43,43,22,28	6.2 ( 29.3 )	7.0 ( 27.8 )	13.6 ( 33.6 )	2.4 ( 33.9 )
CFB in Apettite Loss,Week 6N=33,35,16,27	-5.1 ( 29.0 )	0.0 ( 37.0 )	-4.2 ( 16.7 )	-3.7 ( 36.2 )
CFB in Apettite Loss,Week 9N=28,30,18,21	3.6 ( 36.7 )	2.2 ( 38.1 )	1.9 ( 37.0 )	-4.8 ( 33.8 )
CFB in Apettite Loss,Week 12 N=31,33,16,18	5.4 ( 44.8 )	-1.0 ( 32.8 )	-2.1 ( 22.7 )	7.4 ( 50.6 )
CFB in Apettite Loss,Week 15 N=31,29,12,17	6.5 ( 37.9 )	2.3 ( 36.7 )	8.3 ( 28.9 )	5.9 ( 29.4 )
CFB in Apettite Loss,Week 18N=28,26,11,15	1.2 ( 32.1 )	2.6 ( 37.6 )	3.0 ( 37.9 )	0.0 ( 39.8 )
CFB in Apettite Loss,Week 21N=24,24,12,13	6.9 ( 42.8 )	9.7 ( 39.9 )	13.9 ( 38.8 )	2.6 ( 39.6 )
CFB in Apettite Loss,Week 24 N=21,18,13,9	3.2 ( 27.7 )	1.9 ( 33.3 )	5.1 ( 32.9 )	7.4 ( 36.4 )
CFB in Apettite Loss,Week 27N=16,15,5,5	14.6 ( 34.4 )	4.4 ( 30.5 )	6.7 ( 14.9 )	13.3 ( 38.0 )
CFB in Apettite Loss,Week 90N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Constipation,Baseline N=51,50,28,37	23.5 ( 30.0 )	27.3 ( 30.6 )	25.0 ( 29.6 )	21.6 ( 28.6 )
CFB inConstipation,Week 3 N=42,43,23,29	0.8 ( 23.8 )	-3.1 ( 33.2 )	5.8 ( 32.8 )	2.3 ( 21.7 )
CFB inConstipation,Week 6 N=32,36,16,27	-6.3 ( 33.3 )	-1.9 ( 33.8 )	0.0 ( 32.2 )	0.0 ( 20.7 )
CFB inConstipation,Week 9 N=27,30,19,21	3.7 ( 32.5 )	-2.2 ( 38.1 )	-7.0 ( 23.8 )	1.6 ( 26.8 )
CFB inConstipation,Week 12 N=30,34,17,18	-2.2 ( 36.0 )	-1.0 ( 32.3 )	-2.0 ( 27.6 )	3.7 ( 27.7 )
CFB inConstipation,Week 15 N=31,29,13,18	-2.2 ( 31.0 )	-2.3 ( 39.8 )	0.0 ( 36.0 )	11.1 ( 36.2 )
CFB inConstipation,Week 18 N=28,26,11,15	-7.1 ( 31.9 )	-3.8 ( 38.1 )	0.0 ( 14.9 )	6.7 ( 31.4 )
CFB inConstipation,Week 21 N=23,24,12,13	-7.2 ( 31.7 )	1.4 ( 39.9 )	-8.3 ( 25.1 )	5.1 ( 23.0 )
CFB inConstipation,Week 24 N=20,18,13,9	-10.0 ( 40.6 )	1.9 ( 47.8 )	-5.1 ( 23.0 )	0.0 ( 23.6 )
CFB inConstipation,Week 27 N=15,15,5,5	-6.7 ( 42.2 )	4.4 ( 41.5 )	-6.7 ( 14.9 )	0.0 ( 23.6 )
CFB inConstipation,Week 90 N=1,0,0,0	-33.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Diarrhoea,BaselineN=51,50,28,37	5.2 ( 12.2 )	8.7 ( 20.0 )	2.4 ( 8.7 )	7.2 ( 17.8 )
CFB in Diarrhoea,Week 3 N=42,43,23,29	4.0 ( 16.8 )	0.8 ( 21.2 )	10.1 ( 23.4 )	5.7 ( 33.4 )
CFB in Diarrhoea,Week 6 N=32,36,16,26	0.0 ( 14.7 )	-1.9 ( 17.7 )	4.2 ( 11.4 )	3.8 ( 35.7 )
CFB in Diarrhoea,Week 9 N=27,30,18,21	6.2 ( 26.2 )	-1.1 ( 22.3 )	9.3 ( 25.1 )	-1.6 ( 19.7 )
CFB in Diarrhoea,Week N=31,33,17,18	4.3 ( 20.6 )	0.0 ( 18.6 )	5.9 ( 13.1 )	7.4 ( 21.6 )
CFB in Diarrhoea,Week15 N=30,29,13,18	8.9 ( 26.2 )	-3.4 ( 24.1 )	10.3 ( 21.0 )	11.1 ( 32.3 )
CFB in Diarrhoea,Week18 N=28,25,11,15	0.0 ( 15.7 )	-4.0 ( 20.0 )	6.1 ( 13.5 )	11.1 ( 24.1 )
CFB in Diarrhoea,Week21 N=23,24,10,13	0.0 ( 10.1 )	4.2 ( 22.7 )	6.7 ( 14.1 )	17.9 ( 22.0 )
CFB in Diarrhoea,Week 24 N=20,18,13,9	1.7 ( 13.1 )	-7.4 ( 18.3 )	10.3 ( 21.0 )	14.8 ( 37.7 )
CFB in Diarrhoea,Week at Wk 27 N=15,15,6,5	6.7 ( 13.8 )	-4.4 ( 27.8 )	11.1 ( 17.2 )	13.3 ( 38.0 )
CFB in Diarrhoea,Week at Wk 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Financial Difficulties:BaselineN=51,48,28,34	16.3 ( 26.1 )	22.2 ( 32.5 )	17.9 ( 29.4 )	14.7 ( 29.8 )
CFBinFinancialDifficulties,Week 3 N=42,42,23,26	-2.4 ( 26.9 )	1.6 ( 32.9 )	5.8 ( 21.7 )	-2.6 ( 20.9 )
CFBinFinancialDifficulties,Week 6 N=32,35,16,24	-2.1 ( 18.8 )	2.9 ( 31.7 )	6.3 ( 25.0 )	1.4 ( 20.8 )
CFBinFinancialDifficulties,Week 9 N=27,29,18,19	-1.2 ( 29.9 )	3.4 ( 25.7 )	-1.9 ( 13.9 )	-7.0 ( 30.6 )
CFBinFinancialDifficulties,Week 12 N=31,33,17,16	3.2 ( 32.6 )	8.1 ( 28.9 )	0.0 ( 16.7 )	6.3 ( 32.7 )
CFBinFinancialDifficulties,Week 15 N=30,28,13,17	8.9 ( 30.2 )	1.2 ( 32.1 )	-5.1 ( 18.5 )	0.0 ( 23.6 )
CFBinFinancialDifficulties,Week 18 N=28,24,11,13	0.0 ( 24.0 )	2.8 ( 16.8 )	-3.0 ( 10.1 )	-5.1 ( 35.6 )
CFBinFinancialDifficulties,Week 21 N=23,23,10,11	0.0 ( 22.5 )	0.0 ( 28.4 )	-3.3 ( 10.5 )	-3.0 ( 31.5 )
CFBinFinancialDifficulties,Week 24 N=20,17,13,7	5.0 ( 12.2 )	5.9 ( 21.2 )	0.0 ( 13.6 )	19.0 ( 32.5 )
CFBinFinancialDifficulties,Week 27 N=15,14,6,4	8.9 ( 15.3 )	4.8 ( 17.8 )	0.0 ( 21.1 )	9999 ( 9999 )
CFBinFinancialDifficulties,Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H and N35)

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End point title

Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H and N35) ^[16]

End point description

The H and N cancer is a 35-item questionnaire for participants with H and N cancer. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items: teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain. Using a 4-point Likert scale, participants indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems. Phase 2 Cohort 1: Participants in the ITT Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in the mITT Analysis Set with available data were analyzed. '999'means Standard Deviation cannot be calculated for 1 participant. '9999' means data was not available as no participants were analyzed at specified timepoint..

End point type

Secondary

End point timeframe

Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	52	49	28	37
Units: score on scale
arithmetic mean (standard deviation)
Pain, Baseline N=52,49,28,37	27.1 ( 30.6 )	26.7 ( 24.8 )	28.7 ( 25.2 )	25.0 ( 25.4 )
CFB in Pain, Week3 N=42,42,23,29	-2.8 ( 27.3 )	3.0 ( 22.8 )	6.0 ( 15.3 )	-5.7 ( 21.9 )
CFB in Pain, Week6 N=32,36,16,27	-4.7 ( 22.7 )	-2.9 ( 31.8 )	0.0 ( 23.6 )	-4.6 ( 23.7 )
CFB in Pain, Week9 N=28,29,19,21	-2.1 ( 24.5 )	-3.2 ( 22.4 )	2.3 ( 33.1 )	-6.0 ( 29.1 )
CFB in Pain, Week 12 N=32,33,17,19	-5.2 ( 24.7 )	-7.9 ( 29.1 )	-4.6 ( 26.5 )	3.9 ( 21.2 )
CFB in Pain, Week 15 N=31,28,13,18	2.4 ( 25.6 )	-5.7 ( 30.6 )	-5.8 ( 24.9 )	-7.4 ( 28.9 )
CFB in Pain, Week 18 N=28,26,11,14	-2.1 ( 21.7 )	-10.3 ( 29.1 )	6.8 ( 16.2 )	-1.2 ( 15.3 )
CFB in Pain, Week 21 N=24,24,11,13	2.1 ( 27.6 )	-1.7 ( 34.6 )	-6.8 ( 19.3 )	-4.5 ( 31.1 )
CFB in Pain, Week24 N=21,17,13,9	-3.6 ( 21.8 )	-11.8 ( 37.6 )	-4.5 ( 15.1 )	2.2 ( 24.6 )
CFB in Pain, Week 27 N=16,15,6,5	-4.2 ( 24.7 )	-10.6 ( 36.1 )	-6.9 ( 24.4 )	5.0 ( 22.5 )
CFB in Pain, Week 90 N=1,0,0,0	-58.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Swallowing, Baseline N=51,49,28,36	30.1 ( 33.2 )	33.6 ( 34.8 )	31.0 ( 26.1 )	36.3 ( 31.9 )
CFBinSwallowing,Week 3 N=41,40,23,28	-4.3 ( 24.6 )	2.3 ( 24.5 )	4.1 ( 21.3 )	-3.4 ( 20.9 )
CFBinSwallowing,Week 6 N=30,35,16,26	-9.7 ( 22.5 )	-8.3 ( 29.7 )	-3.1 ( 22.1 )	-7.7 ( 24.5 )
CFBinSwallowing,Week 9 N=28,29,19,21	-5.9 ( 24.0 )	-6.6 ( 24.9 )	0.4 ( 25.5 )	-9.0 ( 31.1 )
CFBinSwallowing,Week 12 N=31,32,17,19	-6.9 ( 25.0 )	-3.3 ( 21.5 )	-5.4 ( 15.9 )	-3.5 ( 20.8 )
CFBinSwallowing,Week 15 N=31,28,13,18	-3.0 ( 29.2 )	-0.3 ( 23.0 )	-8.3 ( 19.2 )	-8.3 ( 23.7 )
CFBinSwallowing,Week 18 N=28,26,11,14	-5.1 ( 28.9 )	0.0 ( 32.8 )	-2.3 ( 10.6 )	-3.6 ( 15.6 )
CFBinSwallowing,Week 21 N=23,24,11,13	-2.2 ( 25.0 )	5.7 ( 33.3 )	-3.8 ( 13.6 )	-15.0 ( 29.8 )
CFBinSwallowing,Week 24 N=20,17,13,9	-3.3 ( 23.0 )	-1.0 ( 8.1 )	-2.6 ( 18.4 )	0.0 ( 20.4 )
CFBinSwallowing,Week at Wk 27 N=16,15,6,5	5.7 ( 22.7 )	-5.6 ( 21.1 )	-13.9 ( 11.4 )	-1.7 ( 12.4 )
CFBinSwallowing,Week at Wk 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Senses Problems, Baseline N=52,49,28,36	16.0 ( 25.8 )	23.5 ( 30.6 )	18.5 ( 26.2 )	29.2 ( 29.4 )
CFB in Senses Problems, Week 3 N=42,42,23,29	-0.4 ( 21.0 )	-1.2 ( 21.3 )	0.7 ( 19.8 )	-4.0 ( 25.8 )
CFB in Senses Problems, Week 6 N=32,36,16,27	-4.2 ( 21.2 )	2.8 ( 30.5 )	9.4 ( 14.9 )	1.9 ( 22.3 )
CFB in Senses Problems, Week 9 N=28,29,19,21	-3.6 ( 21.4 )	0.6 ( 22.9 )	3.5 ( 28.1 )	0.8 ( 18.6 )
CFB in Senses Problems, Week 12 N=32,33,17,19	2.1 ( 14.5 )	-2.5 ( 24.3 )	-4.9 ( 28.1 )	3.5 ( 27.5 )
CFB in Senses Problems, Week 15 N=32,28,13,18	1.0 ( 25.4 )	0.6 ( 25.0 )	-2.6 ( 16.5 )	3.7 ( 16.7 )
CFB in Senses Problems, Week 18 N=28,26,11,14	4.2 ( 27.8 )	-7.1 ( 17.1 )	-1.5 ( 11.7 )	6.0 ( 26.6 )
CFB in Senses Problems, Week 21 N=24,24,11,13	3.5 ( 26.5 )	4.9 ( 31.3 )	1.5 ( 13.9 )	-1.3 ( 19.8 )
CFB in Senses Problems, Week 24 N=21,17,13,9	2.4 ( 29.0 )	3.9 ( 25.4 )	-1.3 ( 12.7 )	-3.7 ( 27.4 )
CFB in Senses Problems, Week 27 N=16,15,6,5	8.3 ( 40.4 )	-2.2 ( 17.7 )	-5.6 ( 13.6 )	13.3 ( 13.9 )
CFB in Senses Problems, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Speech Problems, Baseline N=51,48,28,36	36.2 ( 32.7 )	32.1 ( 31.0 )	32.1 ( 27.8 )	29.3 ( 30.8 )
CFB in Speech Problems, Week 3 N=40,40,23,28	-6.7 ( 22.2 )	-1.1 ( 19.9 )	0.5 ( 19.1 )	4.2 ( 26.0 )
CFB in Speech Problems, Week 6 N=29,35,16,25	-11.9 ( 21.4 )	-6.3 ( 29.6 )	-2.1 ( 20.8 )	-1.3 ( 27.1 )
CFB in Speech Problems, Week 9 N=26,29,19,20	-9.0 ( 27.9 )	1.0 ( 20.6 )	4.7 ( 20.7 )	-1.7 ( 22.3 )
CFB in Speech Problems, Week 12 N=28,33,17,18	-10.7 ( 23.5 )	-7.4 ( 22.0 )	-7.2 ( 21.1 )	4.3 ( 19.9 )
CFB in Speech Problems, Week 15 N=29,28,13,17	-3.8 ( 27.7 )	-0.6 ( 22.0 )	-12.8 ( 14.9 )	4.6 ( 24.9 )
CFB in Speech Problems, Week 18 N=27,24,11,14	-7.0 ( 24.1 )	-8.3 ( 19.2 )	-4.0 ( 13.4 )	5.6 ( 19.4 )
CFB in Speech Problems, Week 21 N=22,24,12,12	-3.5 ( 20.7 )	3.0 ( 18.9 )	-5.1 ( 18.0 )	6.5 ( 30.9 )
CFB in Speech Problems, Week 24 N=19,17,13,8	-10.5 ( 20.1 )	0.7 ( 17.3 )	-7.7 ( 16.0 )	4.2 ( 22.2 )
CFB in Speech Problems, Week 27 N=14,15,6,4	-6.3 ( 24.2 )	-1.9 ( 17.3 )	-9.3 ( 14.8 )	22.2 ( 24.0 )
CFB in Speech Problems, Week 90 N=1,0,0,0	-22.2 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
TroublewithSocialEating,BaselineN=50,48,28,36	33.8 ( 32.8 )	34.2 ( 28.5 )	28.3 ( 26.7 )	24.8 ( 26.7 )
CFB in SocialEating, Week3 N=40,38,22,28	0.7 ( 31.5 )	0.2 ( 24.8 )	7.4 ( 20.0 )	3.9 ( 14.1 )
CFB in SocialEating, Week6 N=29,34,16,26	-9.2 ( 18.0 )	-6.9 ( 33.0 )	3.0 ( 16.8 )	2.4 ( 25.8 )
CFB in SocialEating, Week9 N=25,27,19,21	-8.2 ( 23.9 )	1.2 ( 24.4 )	4.4 ( 28.8 )	-3.6 ( 17.4 )
CFB in SocialEating, Week12 N=29,32,17,19	-4.9 ( 27.5 )	-9.4 ( 24.2 )	2.5 ( 24.2 )	6.1 ( 15.4 )
CFB in SocialEating, Week15 N=30,28,13,18	-3.0 ( 23.3 )	-1.4 ( 32.9 )	-3.4 ( 22.5 )	8.3 ( 20.0 )
CFB in SocialEating, Week18 N=28,25,11,15	-9.2 ( 21.4 )	0.0 ( 30.8 )	3.5 ( 25.2 )	6.1 ( 24.7 )
CFB in SocialEating, Week21 N=23,23,12,13	-8.0 ( 27.7 )	7.6 ( 28.7 )	4.6 ( 23.8 )	-3.8 ( 20.0 )
CFB in SocialEating, Week24 N=20,16,13,9	-17.1 ( 24.0 )	-1.0 ( 20.4 )	1.7 ( 26.7 )	9.9 ( 23.3 )
CFB in SocialEating, Week27 N=14,14,6,5	-3.6 ( 24.8 )	-1.2 ( 13.8 )	0.5 ( 16.3 )	20.0 ( 19.2 )
CFB in SocialEating, Week90 N=1,0,0,0	-8.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
SocialContact,Baseline N=51,49,28,37	21.4 ( 24.6 )	21.7 ( 28.0 )	15.5 ( 22.2 )	13.4 ( 19.6 )
CFB in SocialContact, Week3 N=40,41,23,29	-3.5 ( 24.4 )	5.4 ( 21.6 )	5.2 ( 19.9 )	6.9 ( 15.0 )
CFB in SocialContact, Week6 N=31,35,16,26	-9.2 ( 13.9 )	-2.7 ( 28.1 )	2.9 ( 22.4 )	10.0 ( 21.5 )
CFB in SocialContact, Week9 N=27,29,19,21	-8.0 ( 17.6 )	1.4 ( 18.5 )	6.8 ( 24.8 )	-0.6 ( 11.7 )
CFB in SocialContact, Week12 N=29,33,17,19	-1.7 ( 18.0 )	-5.4 ( 22.4 )	-2.8 ( 19.0 )	2.5 ( 20.4 )
CFB in SocialContact, Week15 N=30,28,13,18	1.4 ( 28.6 )	-2.1 ( 24.0 )	-5.1 ( 15.7 )	7.0 ( 19.1 )
CFB in SocialContact, Week18 N=28,25,11,15	-1.8 ( 24.6 )	-1.6 ( 22.2 )	-2.4 ( 18.7 )	0.4 ( 15.0 )
CFB in SocialContact, Week21 N=23,24,12,13	-1.9 ( 26.9 )	9.3 ( 18.0 )	-2.2 ( 20.4 )	9.2 ( 23.0 )
CFB in SocialContact, Week24 N=20,17,13,9	-5.1 ( 22.3 )	2.7 ( 11.6 )	0.5 ( 23.2 )	5.2 ( 9.9 )
CFB in SocialContact, Week27 N=14,15,6,5	-4.3 ( 25.8 )	-0.9 ( 19.5 )	-4.4 ( 15.6 )	17.3 ( 28.5 )
CFB in SocialContact, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Less Sexuality, Baseline N=51,45,27,34	34.0 ( 34.8 )	38.9 ( 41.0 )	30.9 ( 29.1 )	40.2 ( 37.9 )
CFB in Less Sexuality, Week 3 N=39,36,21,26	4.3 ( 23.5 )	7.4 ( 37.9 )	9.5 ( 38.6 )	4.5 ( 23.8 )
CFB in Less Sexuality, Week 6 N=28,29,14,23	4.2 ( 28.9 )	16.1 ( 43.3 )	3.6 ( 39.9 )	-3.6 ( 32.6 )
CFB in Less Sexuality, Week 9 N=26,26,16,19	7.1 ( 42.2 )	5.1 ( 39.4 )	18.7 ( 43.4 )	1.8 ( 31.4 )
CFB in Less Sexuality, Week 12 N=27,28,15,17	0.6 ( 32.2 )	5.4 ( 36.3 )	22.2 ( 40.7 )	2.9 ( 30.2 )
CFB in Less Sexuality, Week 15 N=28,24,12,16	9.5 ( 43.4 )	9.0 ( 42.3 )	2.8 ( 48.6 )	2.1 ( 30.4 )
CFB in Less Sexuality, Week 18 N=26,20,9,12	-3.2 ( 33.7 )	2.5 ( 39.5 )	5.6 ( 39.1 )	-5.6 ( 32.0 )
CFB in Less Sexuality, Week 21 N=23,20,10,11	-2.9 ( 42.8 )	0.8 ( 39.2 )	21.7 ( 36.9 )	3.0 ( 38.6 )
CFB in Less Sexuality, Week 24 N=19,13,10,7	-0.9 ( 23.9 )	7.7 ( 47.4 )	11.7 ( 27.3 )	-9.5 ( 41.8 )
CFB in Less Sexuality, Week 27 N=13,12,4,3	9.0 ( 23.2 )	6.9 ( 47.9 )	-25.0 ( 50.0 )	-33.3 ( 57.7 )
CFB in Less Sexuality, Week 90 N=1,0,0,0	-33.3 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Teeth, Baseline N=50,46,28,36	21.3 ( 33.5 )	16.7 ( 28.8 )	14.3 ( 32.0 )	30.6 ( 37.7 )
CFB in Teeth, Week3 N=41,38,23,29	-11.4 ( 36.2 )	-0.9 ( 26.3 )	7.2 ( 24.5 )	-11.5 ( 27.1 )
CFB in Teeth, Week6 N=29,32,16,27	-5.7 ( 25.3 )	-8.3 ( 36.9 )	2.1 ( 14.8 )	-17.3 ( 33.8 )
CFB in Teeth, Week9 N=28,27,19,21	6.0 ( 28.8 )	-2.5 ( 22.5 )	-1.8 ( 36.0 )	-17.5 ( 34.3 )
CFB in Teeth, Week9 12 N=30,29,17,19	6.7 ( 34.4 )	1.1 ( 33.9 )	5.9 ( 29.4 )	-8.8 ( 38.2 )
CFB in Teeth, Week9 15 N=30,25,13,18	0.0 ( 31.6 )	5.3 ( 39.3 )	-12.8 ( 29.0 )	-9.3 ( 35.8 )
CFB in Teeth, Week9 18 N=27,24,11,14	0.0 ( 29.2 )	-1.4 ( 45.6 )	0.0 ( 14.9 )	-16.7 ( 36.4 )
CFB in Teeth, Week9 21 N=24,20,11,13	4.2 ( 30.0 )	10.0 ( 42.0 )	6.1 ( 13.5 )	-5.1 ( 26.7 )
CFB in Teeth, Week24 N=20,14,13,9	3.3 ( 37.3 )	4.8 ( 43.1 )	7.7 ( 20.0 )	-22.2 ( 44.1 )
CFB in Teeth, Week27 N=14,11,6,5	2.4 ( 24.3 )	-6.1 ( 13.5 )	0.0 ( 21.1 )	-20.0 ( 50.6 )
CFB in Teeth, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Opening Mouth, Baseline N=50,48,28,37	32.7 ( 40.7 )	39.6 ( 41.1 )	22.6 ( 32.8 )	37.8 ( 41.7 )
CFB in Opening Mouth, Week3 N=41,41,23,29	-2.4 ( 34.5 )	3.3 ( 30.6 )	11.6 ( 21.6 )	-4.6 ( 19.4 )
CFB in Opening Mouth, Week6 N=31,34,16,27	-6.5 ( 33.8 )	-11.8 ( 24.5 )	10.4 ( 26.4 )	-6.2 ( 29.3 )
CFB in Opening Mouth, Week9 N=27,27,19,21	2.5 ( 34.5 )	-6.2 ( 32.1 )	8.8 ( 36.6 )	-4.8 ( 24.2 )
CFB in Opening Mouth, Week12 N=30,32,17,19	-3.3 ( 35.4 )	-9.4 ( 39.0 )	11.8 ( 23.4 )	0.0 ( 24.8 )
CFB in Opening Mouth, Week15 N=31,27,13,18	0.0 ( 38.5 )	-8.6 ( 45.8 )	7.7 ( 14.6 )	1.9 ( 35.2 )
CFB in Opening Mouth, Week18 N=28,25,11,14	3.6 ( 26.2 )	-6.7 ( 36.0 )	12.1 ( 16.8 )	2.4 ( 27.6 )
CFB in Opening Mouth, Week21 N=23,23,11,13	2.9 ( 26.4 )	1.4 ( 38.2 )	3.0 ( 10.1 )	0.0 ( 27.2 )
CFB in Opening Mouth, Week24 N=20,16,13,9	10.0 ( 28.8 )	-2.1 ( 39.4 )	10.3 ( 21.0 )	-3.7 ( 20.0 )
CFB in Opening Mouth, Week27 N=15,14,6,5	8.9 ( 23.5 )	-16.7 ( 31.4 )	5.6 ( 13.6 )	20.0 ( 29.8 )
CFB in Opening Mouth, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Dry Mouth, Baseline N=52,49,28,37	42.3 ( 35.6 )	38.1 ( 36.0 )	34.5 ( 33.3 )	49.5 ( 37.4 )
CFB in Dry Mouth, Week 3 N=42,42,23,29	-9.5 ( 36.3 )	-0.8 ( 26.0 )	0.0 ( 24.6 )	-12.6 ( 32.6 )
CFB in Dry Mouth, Week 6 N=32,36,16,27	-9.4 ( 30.8 )	0.9 ( 34.3 )	2.1 ( 33.3 )	-13.6 ( 29.6 )
CFB in Dry Mouth, Week 9 N=28,29,19,21	-7.1 ( 43.8 )	-2.3 ( 28.1 )	1.8 ( 32.3 )	-9.5 ( 39.6 )
CFB in Dry Mouth, Week 12 N=32,33,17,19	-3.1 ( 37.3 )	5.1 ( 40.9 )	-3.9 ( 33.1 )	-7.0 ( 17.8 )
CFB in Dry Mouth, Week 15 N=31,28,13,18	-5.4 ( 40.5 )	-1.2 ( 41.1 )	2.6 ( 37.2 )	-1.9 ( 31.3 )
CFB in Dry Mouth, Week 18 N=28,26,11,14	-8.3 ( 35.9 )	-2.6 ( 38.8 )	6.1 ( 46.7 )	-11.9 ( 21.1 )
CFB in Dry Mouth, Week 21 N=24,24,11,13	-4.2 ( 37.2 )	1.4 ( 44.5 )	-3.0 ( 48.2 )	-15.4 ( 29.2 )
CFB in Dry Mouth, Week 24 N=21,17,13,9	-4.8 ( 38.4 )	-11.8 ( 37.2 )	-10.3 ( 37.0 )	-14.8 ( 29.4 )
CFB in Dry Mouth, Week 27 N=16,15,6,5	0.0 ( 42.2 )	-20.0 ( 32.9 )	0.0 ( 51.6 )	6.7 ( 36.5 )
CFB in Dry Mouth, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Sticky Saliva,Baseline N=52,49,28,36	41.0 ( 35.9 )	44.9 ( 36.4 )	38.1 ( 36.0 )	45.4 ( 41.5 )
CFB in Sticky Saliva, Week3 N=42,42,23,28	-7.1 ( 35.7 )	-5.6 ( 36.0 )	1.4 ( 40.8 )	-1.2 ( 27.9 )
CFB in Sticky Saliva, Week6 N=32,36,16,27	-7.3 ( 23.5 )	-8.3 ( 38.5 )	0.0 ( 29.8 )	-1.2 ( 25.3 )
CFB in Sticky Saliva, Week9 N=27,29,19,21	-1.2 ( 38.7 )	10.3 ( 29.7 )	-10.5 ( 35.2 )	3.2 ( 36.4 )
CFB in Sticky Saliva, Week12 N=32,33,17,19	-1.0 ( 35.4 )	-10.1 ( 30.6 )	-15.7 ( 41.0 )	7.0 ( 23.8 )
CFB in Sticky Saliva, Week15 N=32,28,12,18	-1.0 ( 26.1 )	-11.9 ( 39.8 )	-11.1 ( 35.8 )	0.0 ( 30.2 )
CFB in Sticky Saliva, Week18 N=28,26,11,14	-3.6 ( 33.1 )	-10.3 ( 33.7 )	-12.1 ( 45.4 )	2.4 ( 27.6 )
CFB in Sticky Saliva, Week21 N=24,24,11,13	1.4 ( 31.8 )	-12.5 ( 40.3 )	-6.1 ( 41.7 )	5.1 ( 42.7 )
CFB in Sticky Saliva, Week24 N=21,17,13,9	-3.2 ( 29.6 )	-13.7 ( 33.5 )	-7.7 ( 45.4 )	3.7 ( 20.0 )
CFB in Sticky Saliva, Week27 N=16,15,6,5	0.0 ( 24.3 )	-26.7 ( 22.5 )	-5.6 ( 49.1 )	20.0 ( 29.8 )
CFB in Sticky Saliva, Week90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Coughing,Baseline N=52,49,28,37	31.4 ( 28.3 )	32.7 ( 35.7 )	41.7 ( 33.5 )	36.9 ( 30.2 )
CFB in Coughing, Week 3 N=42,41,23,29	0.0 ( 27.5 )	0.0 ( 26.9 )	2.9 ( 22.3 )	0.0 ( 34.5 )
CFB in Coughing, Week 6 N=32,36,16,27	0.0 ( 25.4 )	-4.6 ( 40.0 )	-6.3 ( 21.8 )	1.2 ( 31.3 )
CFB in Coughing, Week 9 N=28,29,19,21	3.6 ( 35.5 )	0.0 ( 33.3 )	-1.8 ( 28.3 )	-1.6 ( 24.7 )
CFB in Coughing, Week 12 N=32,33,17,19	-5.2 ( 26.9 )	-1.0 ( 38.6 )	-7.8 ( 36.4 )	8.8 ( 31.1 )
CFB in Coughing, Week 15 N=31,28,13,18	4.3 ( 30.7 )	-3.6 ( 38.9 )	-2.6 ( 34.6 )	-9.3 ( 25.1 )
CFB in Coughing, Week 18 N=28,26,11,14	-4.8 ( 31.1 )	2.6 ( 37.6 )	0.0 ( 21.1 )	7.1 ( 26.7 )
CFB in Coughing, Week 21 N=24,24,11,13	-1.4 ( 20.8 )	4.2 ( 31.6 )	-6.1 ( 25.0 )	2.6 ( 34.6 )
CFB in Coughing, Week 24 N=21,17,13,9	-1.6 ( 28.8 )	0.0 ( 16.7 )	-17.9 ( 29.2 )	3.7 ( 26.1 )
CFB in Coughing, Week 27 N=16,15,6,5	-2.1 ( 25.7 )	-6.7 ( 36.1 )	0.0 ( 21.1 )	13.3 ( 38.0 )
CFB in Coughing, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Felt Ill, Baseline N=52,47,28,37	24.4 ( 31.0 )	31.9 ( 35.4 )	27.4 ( 27.3 )	22.5 ( 28.4 )
CFB in Felt Ill, Week N=42,41,23,29	1.6 ( 30.3 )	-2.4 ( 28.3 )	11.6 ( 25.8 )	5.7 ( 28.3 )
CFB in Felt Ill, Week 6 N=32,36,16,27	-8.3 ( 29.3 )	-13.0 ( 36.8 )	2.1 ( 19.1 )	-1.2 ( 29.9 )
CFB in Felt Ill, Week 9 N=27,28,18,21	4.9 ( 30.2 )	-10.7 ( 39.6 )	-3.7 ( 22.5 )	0.0 ( 23.6 )
CFB in Felt Ill, Week 12 N=32,32,17,19	1.0 ( 28.7 )	-9.4 ( 31.9 )	-2.0 ( 30.0 )	-1.8 ( 28.3 )
CFB in Felt Ill, Week 15 N=31,28,13,18	5.4 ( 31.1 )	-15.5 ( 36.8 )	2.6 ( 28.7 )	5.6 ( 34.8 )
CFB in Felt Ill, Week 18 N=28,25,11,14	3.6 ( 24.6 )	-10.7 ( 36.9 )	9.1 ( 15.6 )	0.0 ( 29.2 )
CFB in Felt Ill, Week 21 N=24,24,11,13	4.2 ( 17.9 )	5.6 ( 32.1 )	12.1 ( 27.0 )	10.3 ( 41.7 )
CFB in Felt Ill, Week 24 N=21,17,13,9	3.2 ( 20.8 )	-2.0 ( 27.6 )	7.7 ( 20.0 )	11.1 ( 37.3 )
CFB in Felt Ill, Week 27 N=16,15,6,5	10.4 ( 31.5 )	-4.4 ( 27.8 )	5.6 ( 13.6 )	-13.3 ( 38.0 )
CFB in Felt Ill, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Pain Killers, Baseline N=51,49,28,37	78.4 ( 41.5 )	75.5 ( 43.4 )	78.6 ( 41.8 )	78.4 ( 41.7 )
CFB in Pain killers, Week 3 N=41,42,23,28	7.3 ( 34.6 )	7.1 ( 46.3 )	0.0 ( 52.2 )	3.6 ( 42.9 )
CFB in Pain killers, Week 6 N=31,36,16,26	-12.9 ( 42.8 )	-8.3 ( 55.4 )	6.3 ( 68.0 )	-11.5 ( 58.8 )
CFB in Pain killers, Week 9 N=27,29,19,21	-14.8 ( 45.6 )	3.4 ( 32.5 )	-10.5 ( 56.7 )	-14.3 ( 47.8 )
CFB in Pain killers, Week 12 N=30,33,17,19	-20.0 ( 48.4 )	-9.1 ( 52.2 )	-17.6 ( 52.9 )	0.0 ( 33.3 )
CFB in Pain killers, Week 15 N=30,28,13,18	-16.7 ( 64.8 )	-7.1 ( 46.6 )	-30.8 ( 75.1 )	-11.1 ( 47.1 )
CFB in Pain killers, Week 18 N=28,25,11,15	-21.4 ( 63.0 )	-4.0 ( 45.5 )	0.0 ( 77.5 )	-13.3 ( 51.6 )
CFB in Pain killers, Week 21 N=23,24,12,13	-30.4 ( 63.5 )	-12.5 ( 53.7 )	-33.3 ( 65.1 )	-15.4 ( 37.6 )
CFB in Pain killers, Week 24 N=20,16,13,9	-30.0 ( 57.1 )	-25.0 ( 44.7 )	-23.1 ( 59.9 )	-22.2 ( 44.1 )
CFB in Pain killers, Week 27 N=14,15,6,5	-35.7 ( 63.3 )	-13.3 ( 51.6 )	-33.3 ( 51.6 )	-20.0 ( 44.7 )
CFB in Pain killers, Week 90 N=1,0,0,0	-100.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
NutritionalSupplements(NS),BaselineN=50,48,28,37	34.0 ( 47.9 )	47.9 ( 50.5 )	42.9 ( 50.4 )	48.6 ( 50.7 )
CFB in NS, Week 3 N=41,41,23,29	4.9 ( 44.4 )	12.2 ( 51.0 )	13.0 ( 45.8 )	0.0 ( 53.5 )
CFB in NS, Week 6 N=31,36,16,25	-9.7 ( 53.9 )	-5.6 ( 58.3 )	6.3 ( 57.4 )	-12.0 ( 52.6 )
CFB in NS, Week 9 N=27,28,19,20	3.7 ( 64.9 )	-7.1 ( 66.3 )	0.0 ( 57.7 )	5.0 ( 60.5 )
CFB in NS, Week 12 N=29,32,17,19	17.2 ( 65.8 )	-6.3 ( 56.4 )	0.0 ( 50.0 )	-15.8 ( 50.1 )
CFB in NS, Week 15 N=30,27,13,18	3.3 ( 61.5 )	-3.7 ( 58.7 )	-15.4 ( 55.5 )	-11.1 ( 47.1 )
CFB in NS, Week 18 N=28,24,11,15	-7.1 ( 60.4 )	-4.2 ( 62.4 )	0.0 ( 44.7 )	6.7 ( 59.4 )
CFB in NS, Week 21 N=23,23,12,13	4.3 ( 63.8 )	4.3 ( 63.8 )	16.7 ( 57.7 )	23.1 ( 59.9 )
CFB in NS, Week 24 N=20,17,13,9	15.0 ( 48.9 )	11.8 ( 69.7 )	-15.4 ( 55.5 )	-11.1 ( 60.1 )
CFB in NS, Week 27 N=14,14,6,5	14.3 ( 36.3 )	7.1 ( 82.9 )	-16.7 ( 40.8 )	0.0 ( 70.7 )
CFB in NS, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Feeding Tube,Baseline N=50,48,28,37	28.0 ( 45.4 )	27.1 ( 44.9 )	28.6 ( 46.0 )	32.4 ( 47.5 )
CFBinFeedingTube,Week 3 N=41,41,23,29	4.9 ( 38.4 )	4.9 ( 21.8 )	4.3 ( 20.9 )	-6.9 ( 25.8 )
CFBinFeedingTube,Week 6 N=31,35,15,26	0.0 ( 25.8 )	-5.7 ( 33.8 )	-6.7 ( 25.8 )	-7.7 ( 39.2 )
CFBinFeedingTube,Week 9 N=27,28,19,21	-11.1 ( 32.0 )	7.1 ( 26.2 )	5.3 ( 40.5 )	-4.8 ( 38.4 )
CFBinFeedingTube,Week 12 N=29,33,17,19	-3.4 ( 32.5 )	6.1 ( 34.8 )	-5.9 ( 42.9 )	0.0 ( 33.3 )
CFBinFeedingTube,Week 15 N=30,27,13,18	3.3 ( 32.0 )	0.0 ( 27.7 )	-7.7 ( 49.4 )	5.6 ( 23.6 )
CFBinFeedingTube,Week 18 N=28,23,11,15	-3.6 ( 33.1 )	4.3 ( 20.9 )	-9.1 ( 30.2 )	0.0 ( 37.8 )
CFBinFeedingTube,Week 21 N=23,23,12,13	-4.3 ( 36.7 )	4.3 ( 20.9 )	-16.7 ( 38.9 )	7.7 ( 27.7 )
CFBinFeedingTube,Week 24 N=20,17,13,9	0.0 ( 32.4 )	5.9 ( 24.3 )	-15.4 ( 37.6 )	0.0 ( 0.0 )
CFBinFeedingTube,Week 27 N=14,13,6,5	0.0 ( 0.0 )	7.7 ( 27.7 )	-16.7 ( 40.8 )	0.0 ( 0.0 )
CFBinFeedingTube,Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Weight Loss,Baseline N=50,49,28,37	32.0 ( 47.1 )	44.9 ( 50.3 )	28.6 ( 46.0 )	29.7 ( 46.3 )
CFB in WeightLoss, Week 3 N=39,41,23,29	23.1 ( 62.7 )	-4.9 ( 59.0 )	30.4 ( 55.9 )	10.3 ( 61.8 )
CFB in WeightLoss, Week 6 N=30,36,16,26	-6.7 ( 74.0 )	-13.9 ( 59.3 )	12.5 ( 50.0 )	19.2 ( 63.4 )
CFB in WeightLoss, Week 9 N=27,29,19,21	3.7 ( 70.6 )	-17.2 ( 60.2 )	0.0 ( 57.7 )	-9.5 ( 53.9 )
CFB in WeightLoss, Week 12 N=29,33,17,19	-17.2 ( 46.8 )	-18.2 ( 58.4 )	11.8 ( 33.2 )	-5.3 ( 52.4 )
CFB in WeightLoss, Week 15 N=30,28,13,17	13.3 ( 73.0 )	-10.7 ( 73.7 )	15.4 ( 37.6 )	-5.9 ( 65.9 )
CFB in WeightLoss, Week 18 N=28,25,11,15	0.0 ( 60.9 )	-20.0 ( 57.7 )	0.0 ( 44.7 )	6.7 ( 59.4 )
CFB in WeightLoss, Week 21 N=23,24,12,13	4.3 ( 47.5 )	-4.2 ( 75.1 )	25.0 ( 45.2 )	7.7 ( 76.0 )
CFB in WeightLoss, Week 24 N=20,17,13,9	-5.0 ( 39.4 )	-5.9 ( 65.9 )	7.7 ( 49.4 )	33.3 ( 50.0 )
CFB in WeightLoss, Week 27 N=14,15,6,5	0.0 ( 55.5 )	-13.3 ( 74.3 )	0.0 ( 0.0 )	40.0 ( 54.8 )
CFB in WeightLoss, Week 90 N=1,0,0,0	0.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )
Weight Gain; Baseline N=49,49,28,37	14.3 ( 35.4 )	8.2 ( 27.7 )	21.4 ( 41.8 )	18.9 ( 39.7 )
CFB in WeightGain, Week3 N=39,40,23,29	7.7 ( 53.2 )	27.5 ( 55.4 )	4.3 ( 36.7 )	-6.9 ( 53.0 )
CFB in WeightGain, Week6 N=30,36,16,26	10.0 ( 54.8 )	25.0 ( 43.9 )	0.0 ( 63.2 )	7.7 ( 48.4 )
CFB in WeightGain, Week9 N=26,28,18,21	3.8 ( 59.9 )	14.3 ( 44.8 )	5.6 ( 63.9 )	19.0 ( 60.2 )
CFB in WeightGain, Week12 N=28,32,17,19	14.3 ( 52.5 )	6.3 ( 50.4 )	23.5 ( 43.7 )	26.3 ( 56.2 )
CFB in WeightGain, Week15 N=30,28,13,18	6.7 ( 58.3 )	25.0 ( 64.5 )	0.0 ( 40.8 )	11.1 ( 47.1 )
CFB in WeightGain, Week18 N=27,24,11,15	7.4 ( 38.5 )	16.7 ( 56.5 )	-18.2 ( 60.3 )	6.7 ( 59.4 )
CFB in WeightGain, Week21 N=22,24,12,13	18.2 ( 39.5 )	4.2 ( 55.0 )	0.0 ( 73.9 )	15.4 ( 68.9 )
CFB in WeightGain, Week24 N=19,17,13,9	21.1 ( 63.1 )	17.6 ( 52.9 )	0.0 ( 40.8 )	11.1 ( 60.1 )
CFB in WeightGain, Week27 N=14,15,6,5	28.6 ( 61.1 )	33.3 ( 61.7 )	-16.7 ( 40.8 )	20.0 ( 44.7 )
CFB in WeightGain, Week90 N=1,0,0,0	-100.0 ( 999 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Phase 2 Cohorts: Number of Participants with 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score

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End point title

Phase 2 Cohorts: Number of Participants with 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score ^[17]

End point description

EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: No Probs, Slight Probs, Moderate Probs, Severe Probs, and Extreme Probs. Number of participants per category are reported. Phase 2 Cohort 1: Participants in the Intent-to-Treat Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in the Modified Intent-to-Treat Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	51	50	27	36
Units: participants
Mobility:Baseline:NoProblems(Probs)N=51,50,27,36	35	31	19	18
Mobility: Baseline:SlightProbsN=51,50,27,36	9	10	4	7
Mobility Baseline: Moderate Probs N=51,50,27,36	5	7	2	9
Mobility: Baseline:SevereProbsN=51,50,27,36	2	1	2	2
Mob Baseline:ExtremeProbsN=51,50,27,36	0	1	0	0
Mobility: Wk 3 :NoProbsN=42,43,23,30	29	28	13	16
Mobility: Wk 3:SlightProbsN=42,43,23,30	7	10	5	6
Mobility: Wk 3:ModerateProbsN=42,43,23,30	4	3	3	5
Mobility: Wk 3:SevereProbsN=42,43,23,30	2	2	2	2
Mobility: Wk 3:ExtremeProbsN=42,43,23,30	0	0	0	1
Mobility: Wk 6 :NoProbsN=30,40,16,27	17	28	11	12
Mobility: Wk 6:SlightProbsN=30,40,16,27	7	9	3	8
Mobility: Wk 6:ModerateProbsN=30,40,16,27	3	1	2	4
Mobility: Wk 6:SevereProbsN=30,40,16,27	1	1	0	2
Mobility: Wk 6:ExtremeProbsN=30,40,16,27	2	1	0	1
Mobility: Wk 9 :NoProbsN=29,30,19,21	19	21	12	12
Mobility: Wk 9:SlightProbsN=29,30,19,21	5	5	5	4
Mobility: Wk 9:ModerateProbsN=29,30,19,21	4	2	1	4
Mobility: Wk 9:SevereProbsN=29,30,19,21	1	1	1	1
Mobility: Wk 9:ExtremeProbsN=29,30,19,21	0	1	0	0
Mobility: Wk 12 :NoProbsN=31,34,18,19	18	22	12	11
Mobility: Wk 12:SlightProbsN=31,34,18,19	9	6	4	4
Mobility: Wk 12:ModerateProbsN=31,34,18,19	2	4	2	3
Mobility: Wk 12:SevereProbsN=31,34,18,19	1	1	0	0
Mobility: Wk 12:ExtremeProbsN=31,34,18,19	1	1	0	1
Mobility: Wk 15 :NoProbsN=31,31,12,18	22	17	9	9
Mobility: Wk 15:SlightProbsN=31,31,12,18	5	7	2	5
Mobility: Wk 15:ModerateProbsN=31,31,12,18	1	5	0	2
Mobility: Wk 15:SevereProbsN=31,31,12,18	3	1	1	2
Mobility: Wk 15:ExtremeProbsN=31,31,12,18	0	1	0	0
Mobility: Wk 18 :NoProbsN=29,24,11,16	19	18	10	5
Mobility: Wk 18:SlightProbsN=29,24,11,16	5	3	1	7
Mobility: Wk 18:ModerateProbsN=29,24,11,16	2	1	0	2
Mobility: Wk 18:SevereProbsN=29,24,11,16	3	2	0	2
Mobility: Wk 18:ExtremeProbsN=29,24,11,16	0	0	0	0
Mobility: Wk 21 :NoProbsN=24,24,13,12	15	11	9	2
Mobility: Wk 21:SlightProbsN=24,24,13,12	6	8	1	6
Mobility: Wk 21:ModerateProbsN=24,24,13,12	2	3	1	3
Mobility: Wk 21:SevereProbsN=24,24,13,12	1	0	1	1
Mobility: Wk 21:ExtremeProbsN=24,24,13,12	0	2	1	0
Mobility: Wk 24 :NoProbsN=21,18,13,8	15	5	11	3
Mobility: Wk 24:SlightProbsN=21,18,13,8	4	8	0	0
Mobility: Wk 24:ModerateProbsN=21,18,13,8	1	4	2	4
Mobility: Wk 24:SevereProbsN=21,18,13,8	1	1	0	1
Mobility: Wk 24:ExtremeProbsN=21,18,13,8	0	0	0	0
Mobility: Wk 27 :NoProbsN=15,14,6,5	9	7	5	1
Mobility: Wk 27:SlightProbsN=15,14,6,5	4	5	1	0
Mobility: Wk 27:ModerateProbsN=15,14,6,5	2	0	0	3
Mobility: Wk 27:SevereProbsN=15,14,6,5	0	2	0	1
Mobility: Wk 27:ExtremeProbsN=15,14,6,5	0	0	0	0
Mobility: Wk 90 :NoProbsN=1,0,0,0	1	0	0	0
Mobility: Wk 90:SlightProbsN=1,0,0,0	0	0	0	0
Mobility: Wk 90:ModerateProbsN=1,0,0,0	0	0	0	0
Mobility: Wk 90:SevereProbsN=1,0,0,0	0	0	0	0
Mobility: Wk 90:ExtremeProbsN=1,0,0,0	0	0	0	0
Self-Care: Baseline :NoProbsN=50,49,27,36	38	38	23	30
Self-care Baseline:SlightProbsN=50,49,27,36	6	8	3	3
Self-care Baseline:ModerateProbsN=50,49,27,36	3	2	0	2
Self-care Baseline:SevereProbsN=50,49,27,36	3	0	1	1
Self-care Baseline:ExtremeProbsN=50,49,27,36	0	1	0	0
Self-Care: Wk 3 :NoProbsN=42,43,23,30	31	32	16	21
Self-Care: Wk 3:SlightProbsN=42,43,23,30	5	7	5	5
Self-Care: Wk 3:ModerateProbsN=42,43,23,30	5	4	0	2
Self-Care: Wk 3:SevereProbsN=42,43,23,30	1	0	2	2
Self-Care: Wk 3:ExtremeProbsN=42,43,23,30	0	0	0	0
Self-Care: Wk 6 :NoProbsN=30,40,16,27	25	34	13	19
Self-Care: Wk 6:SlightProbsN=30,40,16,27	3	3	3	6
Self-Care: Wk 6:ModerateProbsN=30,40,16,27	1	1	0	0
Self-Care: Wk 6:SevereProbsN=30,40,16,27	0	2	0	2
Self-Care: Wk 6:ExtremeProbsN=30,40,16,27	1	0	0	0
Self-Care: Wk 9 :NoProbsN=29,30,19,21	22	24	16	17
Self-Care: Wk 9:SlightProbsN=29,30,19,21	5	4	2	3
Self-Care: Wk 9:ModerateProbsN=29,30,19,21	2	1	0	1
Self-Care: Wk 9:SevereProbsN=29,30,19,21	0	1	1	0
Self-Care: Wk 9:ExtremeProbsN=29,30,19,21	0	0	0	0
Self-Care: Wk 12 :NoProbsN=31,34,18,19	24	27	15	17
Self-Care: Wk 12:SlightProbsN=31,34,18,19	5	3	2	1
Self-Care: Wk 12:ModerateProbsN=31,34,18,19	0	4	1	0
Self-Care: Wk 12:SevereProbsN=31,34,18,19	2	0	0	1
Self-Care: Wk 12:ExtremeProbsN=31,34,18,19	0	0	0	0
Self-Care: Wk 15 :NoProbsN=31,31,12,18	24	25	10	13
Self-Care: Wk 15:SlightProbsN=31,31,12,18	4	4	1	5
Self-Care: Wk 15:ModerateProbsN=31,31,12,18	2	1	1	0
Self-Care: Wk 15:SevereProbsN=31,31,12,18	1	1	0	0
Self-Care: Wk 15:ExtremeProbsN=31,31,12,18	0	0	0	0
Self-Care: Wk 18 :NoProbsN=29,24,11,16	22	21	10	13
Self-Care: Wk 18:SlightProbsN=29,24,11,16	4	2	1	2
Self-Care: Wk 18:ModerateProbsN=29,24,11,16	1	0	0	1
Self-Care: Wk 18:SevereProbsN=29,24,11,16	2	1	0	0
Self-Care: Wk 18:ExtremeProbsN=29,24,11,16	0	0	0	0
Self-Care: Wk 21 :NoProbsN=24,24,13,12	18	17	12	8
Self-Care: Wk 21:SlightProbsN=24,24,13,12	4	5	1	2
Self-Care: Wk 21:ModerateProbsN=24,24,13,12	1	1	0	2
Self-Care: Wk 21:SevereProbsN=24,24,13,12	0	0	0	0
Self-Care: Wk 21:ExtremeProbsN=24,24,13,12	1	1	0	0
Self-Care: Wk 24 :NoProbsN=21,18,13,8	17	15	11	6
Self-Care: Wk 24:SlightProbsN=21,18,13,8	2	0	1	0
Self-Care: Wk 24:ModerateProbsN=21,18,13,8	2	2	1	2
Self-Care: Wk 24:SevereProbsN=21,18,13,8	0	1	0	0
Self-Care: Wk 24:ExtremeProbsN=21,18,13,8	0	0	0	0
Self-Care: Wk 27 :NoProbsN=15,14,6,5	12	12	6	3
Self-Care: Wk 27:SlightProbsN=15,14,6,5	1	1	0	1
Self-Care: Wk 27:ModerateProbsN=15,14,6,5	2	0	0	1
Self-Care: Wk 27:SevereProbsN=15,14,6,5	0	1	0	0
Self-Care: Wk 27:ExtremeProbsN=15,14,6,5	0	0	0	0
Self-Care: Wk 90 :NoProbsN=1,0,0,0	1	0	0	0
Self-Care: Wk 90:SlightProbsN=1,0,0,0	0	0	0	0
Self-Care: Wk 90:ModerateProbsN=1,0,0,0	0	0	0	0
Self-Care: Wk 90:SevereProbsN=1,0,0,0	0	0	0	0
Self-Care: Wk 90:ExtremeProbsN=1,0,0,0	0	0	0	0
UsualActivitiesBaseline:No Probs N=51,49,26,36	25	24	14	15
UsualActivitiesBaseline:SlightProbsN=51,49,26,36	13	14	9	12
UsualActivitiesBaseline:ModerateProbsN=51,49,26,36	8	7	1	3
UsualActivitiesBaseline:SevereProbsN=51,49,26,36	4	1	2	2
UsualActivitiesBaseline:ExtremeProbsN=51,49,26,36	1	3	0	4
Usual ActivitiesWk Wk 3 :NoProbsN=42,42,23,30	16	19	8	10
UsualActivitiesWk 3:SlightProbsN=42,42,23,30	17	15	9	11
UsualActivitiesWk 3:ModerateProbsN=42,42,23,30	5	6	4	7
UsualActivitiesWk 3:SevereProbsN=42,42,23,30	3	2	1	1
UsualActivitiesWk 3:ExtremeProbsN=42,42,23,30	1	0	1	1
UsualActivitiesWk Wk 6 :NoProbsN=30,40,16,27	16	21	8	12
UsualActivitiesWk 6:SlightProbsN=30,40,16,27	10	12	3	4
UsualActivitiesWk 6:ModerateProbsN=30,40,16,27	2	5	5	5
UsualActivitiesWk 6:SevereProbsN=30,40,16,27	1	1	0	4
UsualActivitiesWk 6:ExtremeProbsN=30,40,16,27	1	1	0	2
UsualActivitiesWk 9 :NoProbsN=29,30,19,21	14	19	10	11
UsualActivitiesWk 9:SlightProbsN=29,30,19,21	11	4	3	7
UsualActivitiesWk 9:ModerateProbsN=29,30,19,21	4	5	6	1
UsualActivitiesWk 9:SevereProbsN=29,30,19,21	0	2	0	2
UsualActivitiesWk 9:ExtremeProbsN=29,30,19,21	0	0	0	0
Usu ActivitiesWk Wk 12 :NoProbsN=31,33,18,19	16	21	13	9
UsualActivitiesWk 12:SlightProbsN=31,33,18,19	10	8	3	7
UsualActivitiesWk 12:ModerateProbsN=31,33,18,19	1	3	2	2
UsualActivitiesWk12:SevereProbsN=31,33,18,19	2	0	0	1
UsualActivitiesWk12:ExtremeProbsN=31,33,18,19	2	1	0	0
UsualActivitiesWk15:NoProbsN=30,30,12,18	15	15	6	7
UsualActivitiesWk15:SlightProbs N=30,30,12,18	8	8	4	7
UsualActivitiesWk 15:ModerateProbsN=30,30,12,18	5	5	2	2
UsualActivitiesWk 15:SevereProbsN=30,30,12,18	2	1	0	0
UsualActivitiesWk 15:ExtremeProbsN=30,30,12,18	0	1	0	2
UsualActivitiesWk 18 :NoProbsN=29,24,11,16	18	15	7	5
UsualActivitiesWk 18:SlightProbsN=29,24,11,16	6	7	4	8
UsualActivitiesWk 18:ModerateProbsN=29,24,11,16	2	2	0	1
UsualActivitiesWk 18:SevereProbsN=29,24,11,16	2	0	0	2
UsualActivitiesWk 18:ExtremeProbsN=29,24,11,16	1	0	0	0
UsualActivitiesWk 21 :NoProbsN=24,23,13,12	15	11	8	2
UsualActivitiesWk 21:SlightProbsN=24,23,13,12	9	9	1	4
UsualActivitiesWk 21:ModerateProbsN=24,23,13,12	0	2	2	5
UsualActivitiesWk 21:SevereProbsN=24,23,13,12	0	0	1	0
UsualActivitiesWk 21:ExtremeProbsN=24,23,13,12	0	1	1	1
Usual ActivitiesWk Wk 24 :NoProbsN=21,17,13,7	12	10	7	2
UsualActivitiesWk 24:SlightProbsN=21,17,13,7	5	4	3	2
UsualActivitiesWk 24:ModerateProbsN=21,17,13,7	2	1	3	3
UsualActivitiesWk 24:SevereProbsN=21,17,13,7	1	2	0	0
UsualActivitiesWk 24:ExtremeProbsN=21,17,13,7	1	0	0	0
Usual ActivitiesWk Wk 27 :NoProbsN=15,14,6,5	8	8	4	1
UsualActivitiesWk 27:SlightProbsN=15,14,6,5	4	3	2	0
UsualActivitiesWk 27:ModerateProbsN=15,14,6,5	3	1	0	3
UsualActivitiesWk 27:SevereProbsN=15,14,6,5	0	2	0	1
UsualActivitiesWk 27:ExtremeProbsN=15,14,6,5	0	0	0	0
Usual ActivitiesWk 90 :NoProbsN=1,0,0,0	1	0	0	0
Usu ActivitiesWk 90:SlightProbsN=1,0,0,0	0	0	0	0
UsualActivitiesWk 90:ModerateProbsN=1,0,0,0	0	0	0	0
UsualActivitiesWk 90:SevereProbsN=1,0,0,0	0	0	0	0
UsualActivitiesWk 90:ExtremeProbsN=1,0,0,0	0	0	0	0
Pain/Discomfort Baseline:NoProbsN=51,50,27,36	9	10	4	7
Pain/DiscomfortBaseline:SlightProbsN=51,50,27,36	19	16	8	12
Pain/DiscomfortBaseline:ModerateProbsN=51,50,27,36	15	15	11	12
Pain/DiscomfortBaseline:SevereProbsN=51,50,27,36	6	8	2	5
Pain/DiscomfortBaseline:ExtremeProbsN=51,50,27,36	2	1	2	0
Pain/Discomfort:Wk 3 :NoProbsN=42,43,23,30	12	12	5	7
Pain/Discomfort:Wk 3:SlightProbsN=42,43,23,30	17	12	5	9
Pain/Discomfort:Wk 3:ModerateProbsN=42,43,23,30	10	15	7	10
Pain/Discomfort:Wk 3:SevereProbsN=42,43,23,30	3	4	5	4
Pain/Discomfort:Wk 3:ExtremeProbsN=42,43,23,30	0	0	1	0
Pain/Discomfort:Wk 6 :NoProbsN=30,40,16,27	10	16	4	6
Pain/Discomfort:Wk 6:SlightProbsN=30,40,16,27	15	10	7	10
Pain/Discomfort:Wk 6:ModerateProbsN=30,40,16,27	5	11	4	8
Pain/Discomfort:Wk 6:SevereProbsN=30,40,16,27	0	3	1	3
Pain/Discomfort:Wk 6:ExtremeProbsN=30,40,16,27	0	0	0	0
Pain/Discomfort:Wk 9 :NoProbsN=29,30,19,21	10	10	6	7
Pain/Discomfort:Wk 9:SlightProbsN=29,30,19,21	9	9	7	5
Pain/Discomfort:Wk 9:ModerateProbsN=29,30,19,21	8	8	5	8
Pain/Discomfort:Wk 9:SevereProbsN=29,30,19,21	2	3	1	0
Pain/Discomfort:Wk 9:ExtremeProbsN=29,30,19,21	0	0	0	1
Pain/Discomfort:Wk 12 :NoProbsN=31,34,18,19	11	11	10	6
Pain/Discomfort:Wk 12:SlightProbsN=31,34,18,19	11	15	4	4
Pain/Discomfort:Wk 12:ModerateProbsN=31,34,18,19	5	6	3	8
Pain/Discomfort:Wk 12:SevereProbsN=31,34,18,19	3	1	1	0
Pain/Discomfort:Wk 12:ExtremeProbsN=31,34,18,19	1	1	0	1
Pain/Discomfort:Wk 15 :NoProbsN=31,31,12,18	10	11	4	4
Pain/Discomfort:Wk 15:SlightProbsN=31,31,12,18	13	7	5	6
Pain/Discomfort:Wk 15:ModerateProbsN=31,31,12,18	5	9	3	8
Pain/Discomfort:Wk 15:SevereProbsN=31,31,12,18	3	3	0	0
Pain/Discomfort:Wk 15:ExtremeProbsN=31,31,12,18	0	1	0	0
Pain/Discomfort:Wk 18 :NoProbsN=29,24,11,16	10	11	4	5
Pain/Discomfort:Wk 18:SlightProbsN=29,24,11,16	11	8	3	7
Pain/Discomfort:Wk 18:ModerateProbsN=29,24,11,16	8	5	4	2
Pain/Discomfort:Wk 18:SevereProbsN=29,24,11,16	0	0	0	2
Pain/Discomfort:Wk 18:ExtremeProbsN=29,24,11,16	0	0	0	0
Pain/Discomfort:Wk 21 :NoProbsN=24,24,13,12	9	11	8	3
Pain/Discomfort:Wk 21:SlightProbsN=24,24,13,12	7	4	2	3
Pain/Discomfort:Wk 21:ModerateProbsN=24,24,13,12	5	6	3	5
Pain/Discomfort:Wk 21:SevereProbsN=24,24,13,12	3	3	0	1
Pain/Discomfort:Wk 21:ExtremeProbsN=24,24,13,12	0	0	0	0
Pain/Discomfort:Wk 24 :NoProbsN=21,18,13,8	7	7	5	3
Pain/Discomfort:Wk 24:SlightProbsN=21,18,13,8	7	4	6	1
Pain/Discomfort:Wk 24:ModerateProbsN=21,18,13,8	7	6	1	3
Pain/Discomfort:Wk 24:SevereProbsN=21,18,13,8	0	0	0	1
Pain/Discomfort:Wk 24:ExtremeProbsN=21,18,13,8	0	1	1	0
Pain/Discomfort:Wk 27 :NoProbsN=15,14,6,5	9	9	4	1
Pain/Discomfort:Wk 27:SlightProbsN=15,14,6,5	1	0	2	1
Pain/Discomfort:Wk 27:ModerateProbsN=15,14,6,5	4	2	0	2
Pain/Discomfort:Wk 27:SevereProbsN=15,14,6,5	1	3	0	0
Pain/Discomfort:Wk 27:ExtremeProbsN=15,14,6,5	0	0	0	1
Pain/Discomfort:Wk 90 :NoProbsN=1,0,0,0	0	0	0	0
Pain/Discomfort:Wk 90:SlightProbsN=1,0,0,0	1	0	0	0
Pain/Discomfort:Wk 90:ModerateProbsN=1,0,0,0	0	0	0	0
Pain/Discomfort:Wk 90:SevereProbsN=1,0,0,0	0	0	0	0
Pain/Discomfort:Wk 90:ExtremeProbsN=1,0,0,0	0	0	0	0
Anxiety/DepressionBaseline:No Probs N=51,50,27,36	20	21	9	22
Anxiety/DepressionBaselineSlightProbsN=51,50,27,36	20	15	12	9
AnxietyDepressionBaselineModerateProbN=51,50,27,36	6	8	5	5
Anxiety/DepressionBaselineSevereProbsN=51,50,27,36	4	3	1	0
AnxietyDepressionBaselineExtremeProbsN=51,50,27,36	1	3	0	0
Anxiety/DepressionWk 3:No Probs N=42,43,23,30	21	23	8	16
Anxiety/DepressionWk3:Slight Probs N=42,43,23,30	15	7	11	10
Anxiety/DepressionWk3:Moderate Probs N=42,43,23,30	3	9	3	3
Anxiety/DepressionWk3:Severe Probs N=42,43,23,30	3	4	1	1
Anxiety/DepressionWk3:Extreme Probs N=42,43,23,30	0	0	0	0
Anxiety/DepressionWk6 :NoProbsN=30,40,16,27	16	19	8	13
Anxiety/DepressionWk6:SlightProbsN=30,40,16,27	13	10	5	8
Anxiety/DepressionWk6:ModerateProbsN=30,40,16,27	1	7	3	5
Anxiety/DepressionWk6:SevereProbsN=30,40,16,27	0	3	0	1
Anxiety/DepressionWk6:ExtremeProbsN=30,40,16,27	0	1	0	0
Anxiety/DepressionWk9 :NoProbsN=29,30,19,21	8	18	8	11
Anxiety/DepressionWk9:SlightProbsN=29,30,19,21	15	8	9	8
Anxiety/DepressionWk9:ModerateProbsN=29,30,19,21	6	3	2	2
Anxiety/DepressionWk9:SevereProbsN=29,30,19,21	0	0	0	0
Anxiety/DepressionWk9:ExtremeProbsN=29,30,19,21	0	1	0	0
Anxiety/DepressionWk12 :NoProbsN=31,34,18,19	14	15	9	9
Anxiety/DepressionWk12:SlightProbsN=31,34,18,19	14	15	9	9
Anxiety/DepressionWk12:ModerateProbsN=31,34,18,19	0	4	0	1
Anxiety/DepressionWk12:SevereProbsN=31,34,18,19	1	0	0	0
Anxiety/DepressionWk12:ExtremeProbsN=31,34,18,19	2	0	0	0
Anxiety/DepressionWk15 :NoProbsN=31,31,12,18	15	14	6	10
Anxiety/DepressionWk15:SlightProbsN=31,31,12,18	11	6	5	4
Anxiety/DepressionWk15:ModerateProbsN=31,31,12,18	3	8	1	4
Anxiety/DepressionWk15:SevereProbsN=31,31,12,18	1	3	0	0
Anxiety/DepressionWk15:ExtremeProbsN=31,31,12,18	1	0	0	0
Anxiety/DepressionWk18 :NoProbsN=29,24,10,15	14	13	4	10
Anxiety/DepressionWk18:SlightProbsN=29,24,10,15	9	6	5	2
Anxiety/DepressionWk18:ModerateProbsN=29,24,10,15	4	5	1	3
Anxiety/DepressionWk18:SevereProbsN=29,24,10,15	2	0	0	0
Anxiety/DepressionWk18:ExtremeProbsN=29,24,10,15	0	0	0	0
Anxiety/DepressionWk21 :NoProbsN=24,24,13,12	12	12	8	2
Anxiety/DepressionWk21:SlightProbsN=24,24,13,12	7	4	4	6
Anxiety/DepressionWk21:ModerateProbsN=24,24,13,12	4	7	1	4
Anxiety/DepressionWk21:SevereProbsN=24,24,13,12	0	1	0	0
Anxiety/DepressionWk21:ExtremeProbsN=24,24,13,12	1	0	0	0
Anxiety/DepressionWk24 :NoProbsN=21,18,13,8	10	10	8	3
Anxiety/DepressionWk24:SlightProbsN=21,18,13,8	8	3	5	2
Anxiety/DepressionWk24:ModerateProbsN=21,18,13,8	2	4	0	3
Anxiety/DepressionWk24:SevereProbsN=21,18,13,8	1	1	0	0
Anxiety/DepressionWk24:ExtremeProbsN=21,18,13,8	0	0	0	0
Anxiety/DepressionWk27 :NoProbsN=15,14,6,5	7	7	4	1
Anxiety/DepressionWk27:SlightProbsN=15,14,6,5	4	4	2	1
Anxiety/DepressionWk27:ModerateProbsN=15,14,6,5	3	1	0	3
Anxiety/DepressionWk27:SevereProbsN=15,14,6,5	1	2	0	0
Anxiety/DepressionWk27:ExtremeProbsN=15,14,6,5	0	0	0	0
Anxiety/Depression:Wk90:No Probs N=1,0,0,0	1	0	0	0
Anxiety/DepressionWk90:Slight Probs N=1,0,0,0	0	0	0	0
Anxiety/DepressionWk90:Moderate Probs N=1,0,0,0	0	0	0	0
Anxiety/DepressionWk90:Severe Probs N=1,0,0,0	0	0	0	0
Anxiety/DepressionWk90:Extreme Probs N=1,0,0,0	0	0	0	0

No statistical analyses for this end point

Secondary: Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score

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End point title

Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score ^[18]

End point description

The EQ-VAS records the participant's self-rated health on a vertical VAS, where the end points are labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS can be used as a quantitative measure of health outcome that reflects the participant's own judgment. Analysis Population Description : Phase 2 Cohort 1: Participants in the Intent-to-Treat Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in the Modified Intent-to-Treat Analysis Set with available data were analyzed. '9999' signifies that data was not available since no participants were analyzed at the specified timepoint. 1111 : Standard Deviation can not be estimated for one participant.

End point type

Secondary

End point timeframe

Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per prespecified analysis, the data for this endpoint was collected only for Phase 2 Cohort 3 and Phase 2 Cohort Arms A, B and C. Hence the data is not reported for Safety Run-In Arms 1 and 2 for this endpoint.

End point values	Ph 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU	Ph 2 Cohort 1 Arm C: Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel
Number of subjects analysed	52	52	32	41
Units: score on scale
arithmetic mean (standard deviation)
Baseline N = 52,50,27,36	61.9 ( 20.96 )	64.0 ( 23.15 )	59.8 ( 24.86 )	62.0 ( 22.21 )
Change at Week 3 N = 41,42,23,27	-3.7 ( 20.80 )	4.3 ( 20.72 )	4.1 ( 17.88 )	-0.3 ( 16.20 )
Change at Week 6 N = 30,38,14,26	2.2 ( 14.82 )	5.7 ( 24.75 )	1.1 ( 15.71 )	-2.1 ( 16.37 )
Change at Week 9 N = 29,29,16,20	-1.0 ( 18.19 )	2.5 ( 16.89 )	6.6 ( 18.50 )	4.4 ( 20.74 )
Change at Week 12 N = 31,32,16,18	4.5 ( 18.65 )	7.9 ( 23.02 )	5.9 ( 19.60 )	-4.5 ( 4.55 )
Change at Week 15 N = 31,29,11,18	0.1 ( 18.79 )	10.5 ( 23.60 )	3.2 ( 15.05 )	-1.1 ( 12.86 )
Change at Week 18 N = 29,25,11,15	-1.2 ( 9.34 )	7.4 ( 23.33 )	3.8 ( 20.11 )	-8.1 ( 17.77 )
Change at Week 21 N = 24,24,11,11	0.5 ( 18.59 )	1.1 ( 21.12 )	4.0 ( 20.15 )	-8.5 ( 16.71 )
Change at Week 24 N = 21,17,12,7	0.2 ( 22.05 )	6.0 ( 22.45 )	2.1 ( 20.72 )	-13.9 ( 19.17 )
Change at Week 27 N = 14,13,6,5	-10.0 ( 19.32 )	-0.9 ( 22.46 )	10.0 ( 1.45 )	-9.0 ( 23.56 )
Change at Week 90 N = 1,0,0,0	25.0 ( 1111 )	9999 ( 9999 )	9999 ( 9999 )	9999 ( 9999 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days

Adverse event reporting additional description

All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

Phase 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU

Reporting group description

Reporting group title

Safety Run-in Cohort 1:Magrolimab+Pembrolizumab+Platinum+5-FU

Reporting group description

Reporting group title

Phase 2 Cohort 3: Magrolimab + Docetaxel

Reporting group description

Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.

Reporting group title

Safety Run-in Cohort 2: Magrolimab + Docetaxel

Reporting group description

Reporting group title

Phase 2 Cohort 1 Arm C:Magrolimab+Zimberelimab+Platinum+5-FU

Reporting group description

Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.

Reporting group title

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Reporting group description

Serious adverse events	Phase 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Safety Run-in Cohort 1:Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 1 Arm C:Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU
Total subjects affected by serious adverse events
subjects affected / exposed	26 / 52 (50.00%)	4 / 6 (66.67%)	24 / 41 (58.54%)	6 / 7 (85.71%)	15 / 29 (51.72%)	24 / 53 (45.28%)
number of deaths (all causes)	25	1	24	6	9	22
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cancer pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tumour pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Peripheral ischaemia
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Superior vena cava syndrome
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Mucosal inflammation
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperthermia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fatigue
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Catheter site haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	2 / 29 (6.90%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 1	0 / 0	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	2 / 29 (6.90%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acquired tracheo-oesophageal fistula
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	2 / 53 (3.77%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Disorientation
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Post procedural haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stoma site discharge
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infusion related reaction
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Seizure
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Middle cerebral artery stroke
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	4 / 41 (9.76%)	2 / 7 (28.57%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	3 / 3	1 / 1	4 / 4	3 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	8 / 41 (19.51%)	3 / 7 (42.86%)	1 / 29 (3.45%)	5 / 53 (9.43%)
occurrences causally related to treatment / all	2 / 2	1 / 1	8 / 8	3 / 3	1 / 1	5 / 5
deaths causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
Splenic haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenic colitis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mouth haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oral cavity fistula
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aphthous ulcer
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic cytolysis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin haemorrhage
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Toxic skin eruption
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	4 / 52 (7.69%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	2 / 29 (6.90%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	4 / 4	0 / 0	0 / 0	0 / 0	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Epididymitis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis cryptosporidial
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Covid-19
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 52 (1.92%)	4 / 6 (66.67%)	6 / 41 (14.63%)	1 / 7 (14.29%)	3 / 29 (10.34%)	2 / 53 (3.77%)
occurrences causally related to treatment / all	1 / 1	2 / 4	2 / 6	0 / 1	1 / 4	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 1	0 / 1	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	2 / 41 (4.88%)	1 / 7 (14.29%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2	0 / 1	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	1 / 1
Sepsis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	3 / 29 (10.34%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection ~ viral
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterocolitis infectious
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatic infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	2 / 53 (3.77%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Oral infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic candida
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Genital herpes simplex
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tongue abscess
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oral fungal infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia necrotising
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular device infection
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tracheitis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Phase 2 Cohort 1 Arm A: Magrolimab+Pembrolizumab+Platinum+5-FU	Safety Run-in Cohort 1:Magrolimab+Pembrolizumab+Platinum+5-FU	Phase 2 Cohort 3: Magrolimab + Docetaxel	Safety Run-in Cohort 2: Magrolimab + Docetaxel	Phase 2 Cohort 1 Arm C:Magrolimab+Zimberelimab+Platinum+5-FU	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU
Total subjects affected by non serious adverse events
subjects affected / exposed	49 / 52 (94.23%)	6 / 6 (100.00%)	40 / 41 (97.56%)	7 / 7 (100.00%)	28 / 29 (96.55%)	53 / 53 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	3	0
Cancer pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	1	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	1 / 7 (14.29%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	0	1	0	1	1	2
Hypotension
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	3 / 41 (7.32%)	2 / 7 (28.57%)	0 / 29 (0.00%)	3 / 53 (5.66%)
occurrences all number	3	0	3	3	0	3
Embolism
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	0	0	0	0	2	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	6 / 52 (11.54%)	3 / 6 (50.00%)	5 / 41 (12.20%)	1 / 7 (14.29%)	3 / 29 (10.34%)	3 / 53 (5.66%)
occurrences all number	8	4	5	2	4	4
Oedema peripheral
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	5 / 41 (12.20%)	1 / 7 (14.29%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	3	0	5	1	2	0
Non-cardiac chest pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Chills
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	1 / 41 (2.44%)	1 / 7 (14.29%)	3 / 29 (10.34%)	1 / 53 (1.89%)
occurrences all number	3	1	1	1	3	1
Mucosal inflammation
subjects affected / exposed	5 / 52 (9.62%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	3 / 29 (10.34%)	4 / 53 (7.55%)
occurrences all number	6	0	0	0	4	4
Fatigue
subjects affected / exposed	12 / 52 (23.08%)	5 / 6 (83.33%)	14 / 41 (34.15%)	4 / 7 (57.14%)	9 / 29 (31.03%)	11 / 53 (20.75%)
occurrences all number	16	5	21	5	12	13
Pain
subjects affected / exposed	4 / 52 (7.69%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	4	0	0	0	0	2
Asthenia
subjects affected / exposed	16 / 52 (30.77%)	1 / 6 (16.67%)	7 / 41 (17.07%)	0 / 7 (0.00%)	10 / 29 (34.48%)	15 / 53 (28.30%)
occurrences all number	17	1	9	0	10	17
Influenza like illness
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	1	2	1	0	0	1
Respiratory, thoracic and mediastinal disorders
Hiccups
subjects affected / exposed	0 / 52 (0.00%)	2 / 6 (33.33%)	2 / 41 (4.88%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	2	2	0	0	0
Haemoptysis
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	1 / 7 (14.29%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	1	0	1	1	1	2
Cough
subjects affected / exposed	5 / 52 (9.62%)	1 / 6 (16.67%)	5 / 41 (12.20%)	1 / 7 (14.29%)	5 / 29 (17.24%)	7 / 53 (13.21%)
occurrences all number	6	1	5	1	5	9
Dysphonia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	0	0	1	0	2	0
Dyspnoea exertional
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	0	0	1	0	0
Dyspnoea
subjects affected / exposed	8 / 52 (15.38%)	0 / 6 (0.00%)	10 / 41 (24.39%)	1 / 7 (14.29%)	5 / 29 (17.24%)	6 / 53 (11.32%)
occurrences all number	8	0	13	1	6	6
Tracheal inflammation
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Pleural effusion
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences all number	0	0	0	1	1	3
Rhinorrhoea
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	0	1	0	0	0	2
Pneumonitis
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	0	1	0	0	0	1
Laryngeal inflammation
subjects affected / exposed	4 / 52 (7.69%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	4	0	0	0	0	1
Increased bronchial secretion
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Productive cough
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	1 / 7 (14.29%)	3 / 29 (10.34%)	1 / 53 (1.89%)
occurrences all number	2	1	0	1	3	1
Oropharyngeal pain
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	2 / 53 (3.77%)
occurrences all number	1	1	1	0	0	2
Psychiatric disorders
Insomnia
subjects affected / exposed	5 / 52 (9.62%)	1 / 6 (16.67%)	3 / 41 (7.32%)	1 / 7 (14.29%)	3 / 29 (10.34%)	4 / 53 (7.55%)
occurrences all number	5	1	3	1	3	4
Anxiety
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences all number	1	1	1	0	1	1
Depression
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	0	1	1	0	0	1
Investigations
Neutrophil count decreased
subjects affected / exposed	11 / 52 (21.15%)	2 / 6 (33.33%)	9 / 41 (21.95%)	4 / 7 (57.14%)	4 / 29 (13.79%)	2 / 53 (3.77%)
occurrences all number	18	2	14	8	15	2
Weight decreased
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	2 / 41 (4.88%)	2 / 7 (28.57%)	5 / 29 (17.24%)	7 / 53 (13.21%)
occurrences all number	3	0	2	2	5	7
Aspartate aminotransferase increased
subjects affected / exposed	4 / 52 (7.69%)	2 / 6 (33.33%)	2 / 41 (4.88%)	0 / 7 (0.00%)	3 / 29 (10.34%)	5 / 53 (9.43%)
occurrences all number	5	2	2	0	4	5
Platelet count decreased
subjects affected / exposed	8 / 52 (15.38%)	5 / 6 (83.33%)	1 / 41 (2.44%)	3 / 7 (42.86%)	8 / 29 (27.59%)	8 / 53 (15.09%)
occurrences all number	18	7	2	6	22	13
Blood thyroid stimulating hormone increased
subjects affected / exposed	4 / 52 (7.69%)	3 / 6 (50.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	4	3	2	0	2	4
Blood iron decreased
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	0	0	1	0	0
Alanine aminotransferase increased
subjects affected / exposed	5 / 52 (9.62%)	1 / 6 (16.67%)	4 / 41 (9.76%)	1 / 7 (14.29%)	3 / 29 (10.34%)	5 / 53 (9.43%)
occurrences all number	5	2	4	1	5	5
Haemoglobin decreased
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	3 / 53 (5.66%)
occurrences all number	2	0	1	0	1	3
Blood creatinine increased
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	4 / 29 (13.79%)	2 / 53 (3.77%)
occurrences all number	4	1	0	0	4	2
Lymphocyte count decreased
subjects affected / exposed	6 / 52 (11.54%)	1 / 6 (16.67%)	4 / 41 (9.76%)	0 / 7 (0.00%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	6	1	4	0	3	0
White blood cell count decreased
subjects affected / exposed	11 / 52 (21.15%)	4 / 6 (66.67%)	8 / 41 (19.51%)	2 / 7 (28.57%)	4 / 29 (13.79%)	4 / 53 (7.55%)
occurrences all number	18	6	13	5	7	5
Blood alkaline phosphatase increased
subjects affected / exposed	7 / 52 (13.46%)	1 / 6 (16.67%)	2 / 41 (4.88%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	11	1	2	0	1	2
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	3 / 53 (5.66%)
occurrences all number	1	0	1	0	0	3
C-reactive protein increased
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	1	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	1 / 7 (14.29%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	1	0	1	1	0	1
Stoma site pain
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	0	0	1	0	0
Limb injury
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Infusion related reaction
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	3 / 41 (7.32%)	1 / 7 (14.29%)	6 / 29 (20.69%)	1 / 53 (1.89%)
occurrences all number	3	1	3	1	6	1
Cardiac disorders
Ventricular hypokinesia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Atrial flutter
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	0	0	2	0	0
Cardiac failure congestive
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Nervous system disorders
Headache
subjects affected / exposed	10 / 52 (19.23%)	1 / 6 (16.67%)	7 / 41 (17.07%)	2 / 7 (28.57%)	8 / 29 (27.59%)	5 / 53 (9.43%)
occurrences all number	12	1	8	3	11	7
Polyneuropathy
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	3 / 41 (7.32%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	0	0	3	0	1	0
Dizziness
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	1 / 41 (2.44%)	1 / 7 (14.29%)	1 / 29 (3.45%)	5 / 53 (9.43%)
occurrences all number	6	0	1	1	1	6
Peripheral sensory neuropathy
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	2 / 41 (4.88%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	2	1	2	0	0	1
Disturbance in attention
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Brain fog
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Neuropathy peripheral
subjects affected / exposed	1 / 52 (1.92%)	3 / 6 (50.00%)	4 / 41 (9.76%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	2	4	5	1	0	0
Presyncope
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	3	2	0	0	1	0
Dysgeusia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	2 / 41 (4.88%)	2 / 7 (28.57%)	3 / 29 (10.34%)	1 / 53 (1.89%)
occurrences all number	2	0	2	2	3	1
Blood and lymphatic system disorders
Lymphopenia
subjects affected / exposed	9 / 52 (17.31%)	0 / 6 (0.00%)	5 / 41 (12.20%)	0 / 7 (0.00%)	2 / 29 (6.90%)	6 / 53 (11.32%)
occurrences all number	19	0	8	0	2	7
Leukopenia
subjects affected / exposed	4 / 52 (7.69%)	0 / 6 (0.00%)	2 / 41 (4.88%)	1 / 7 (14.29%)	4 / 29 (13.79%)	7 / 53 (13.21%)
occurrences all number	8	0	5	1	5	10
Thrombocytopenia
subjects affected / exposed	16 / 52 (30.77%)	1 / 6 (16.67%)	4 / 41 (9.76%)	0 / 7 (0.00%)	5 / 29 (17.24%)	20 / 53 (37.74%)
occurrences all number	27	1	6	0	6	27
Anaemia
subjects affected / exposed	43 / 52 (82.69%)	5 / 6 (83.33%)	28 / 41 (68.29%)	5 / 7 (71.43%)	21 / 29 (72.41%)	37 / 53 (69.81%)
occurrences all number	66	10	38	10	28	45
Haemolysis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Febrile neutropenia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	1 / 41 (2.44%)	1 / 7 (14.29%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	2	0	1	1	0	1
Neutropenia
subjects affected / exposed	16 / 52 (30.77%)	1 / 6 (16.67%)	8 / 41 (19.51%)	1 / 7 (14.29%)	7 / 29 (24.14%)	12 / 53 (22.64%)
occurrences all number	28	2	12	1	8	17
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	3	0	1	0	0	1
Vertigo
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	2	0	0	1	1	0
Ear pain
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	2 / 29 (6.90%)	2 / 53 (3.77%)
occurrences all number	0	0	2	0	2	2
Tinnitus
subjects affected / exposed	6 / 52 (11.54%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	7	0	1	0	0	1
Eye disorders
Blindness unilateral
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Vision blurred
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	1	0	0	1	0	1
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	11 / 52 (21.15%)	3 / 6 (50.00%)	14 / 41 (34.15%)	2 / 7 (28.57%)	7 / 29 (24.14%)	13 / 53 (24.53%)
occurrences all number	12	4	19	4	9	19
Dry mouth
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	2	1	0	0	1	2
Nausea
subjects affected / exposed	19 / 52 (36.54%)	4 / 6 (66.67%)	15 / 41 (36.59%)	2 / 7 (28.57%)	11 / 29 (37.93%)	23 / 53 (43.40%)
occurrences all number	27	6	18	3	15	27
Stomatitis
subjects affected / exposed	7 / 52 (13.46%)	5 / 6 (83.33%)	10 / 41 (24.39%)	2 / 7 (28.57%)	9 / 29 (31.03%)	18 / 53 (33.96%)
occurrences all number	9	12	12	2	15	25
Abdominal pain
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	4 / 41 (9.76%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	1	0	4	0	0	1
Abdominal pain upper
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	3 / 53 (5.66%)
occurrences all number	1	0	0	0	1	5
Abdominal distension
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	2 / 29 (6.90%)	1 / 53 (1.89%)
occurrences all number	0	0	1	0	2	1
Oral dysaesthesia
subjects affected / exposed	0 / 52 (0.00%)	2 / 6 (33.33%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	2	0	0	0	0
Dysphagia
subjects affected / exposed	4 / 52 (7.69%)	0 / 6 (0.00%)	5 / 41 (12.20%)	0 / 7 (0.00%)	1 / 29 (3.45%)	5 / 53 (9.43%)
occurrences all number	4	0	5	0	1	5
Constipation
subjects affected / exposed	18 / 52 (34.62%)	3 / 6 (50.00%)	7 / 41 (17.07%)	1 / 7 (14.29%)	4 / 29 (13.79%)	16 / 53 (30.19%)
occurrences all number	22	4	8	1	5	17
Glossodynia
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	1	1	0	0	1	0
Gastrooesophageal reflux disease
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	3 / 41 (7.32%)	0 / 7 (0.00%)	1 / 29 (3.45%)	5 / 53 (9.43%)
occurrences all number	2	0	3	0	1	5
Vomiting
subjects affected / exposed	6 / 52 (11.54%)	1 / 6 (16.67%)	6 / 41 (14.63%)	0 / 7 (0.00%)	7 / 29 (24.14%)	7 / 53 (13.21%)
occurrences all number	13	2	8	0	8	7
Oral pain
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	2 / 41 (4.88%)	0 / 7 (0.00%)	3 / 29 (10.34%)	3 / 53 (5.66%)
occurrences all number	1	1	2	0	3	3
Dyspepsia
subjects affected / exposed	4 / 52 (7.69%)	1 / 6 (16.67%)	3 / 41 (7.32%)	0 / 7 (0.00%)	3 / 29 (10.34%)	3 / 53 (5.66%)
occurrences all number	4	1	3	0	5	3
Skin and subcutaneous tissue disorders
Rash pruritic
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Dry skin
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	2	1	1	0	1	2
Alopecia
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	9 / 41 (21.95%)	0 / 7 (0.00%)	3 / 29 (10.34%)	1 / 53 (1.89%)
occurrences all number	0	0	9	0	3	1
Rash
subjects affected / exposed	5 / 52 (9.62%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences all number	5	1	1	0	1	1
Skin hyperpigmentation
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Rash maculo-papular
subjects affected / exposed	4 / 52 (7.69%)	3 / 6 (50.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	1 / 29 (3.45%)	3 / 53 (5.66%)
occurrences all number	4	3	0	0	1	3
Skin hypopigmentation
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Actinic keratosis
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Skin fissures
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	2	1	0	0	0	0
Pruritus
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	3 / 41 (7.32%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	3	1	3	0	1	2
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	2	0	0	0	0
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	1	1	0	0	0
Proteinuria
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	0	1	0	0	0	1
Pollakiuria
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	2	1	0	0	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	3 / 52 (5.77%)	1 / 6 (16.67%)	2 / 41 (4.88%)	0 / 7 (0.00%)	1 / 29 (3.45%)	4 / 53 (7.55%)
occurrences all number	3	1	5	0	1	4
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	3 / 41 (7.32%)	0 / 7 (0.00%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	0	0	3	0	1	0
Pain in jaw
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	1 / 29 (3.45%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	1	0
Muscle tightness
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	2	1	0	0	0	0
Myalgia
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	2	1	1	0	0	1
Neck pain
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	4 / 53 (7.55%)
occurrences all number	1	0	1	0	0	4
Arthralgia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	2 / 41 (4.88%)	1 / 7 (14.29%)	4 / 29 (13.79%)	4 / 53 (7.55%)
occurrences all number	2	0	2	1	4	5
Back pain
subjects affected / exposed	5 / 52 (9.62%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	4 / 29 (13.79%)	0 / 53 (0.00%)
occurrences all number	5	0	0	1	4	0
Pain in extremity
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	3	0	2	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	1	0	0	0	2	0
Infections and infestations
Pneumonia
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	3 / 41 (7.32%)	0 / 7 (0.00%)	0 / 29 (0.00%)	4 / 53 (7.55%)
occurrences all number	6	0	3	0	0	4
Respiratory tract infection
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	1 / 29 (3.45%)	3 / 53 (5.66%)
occurrences all number	2	0	2	0	1	3
Candida infection
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	1 / 41 (2.44%)	1 / 7 (14.29%)	0 / 29 (0.00%)	2 / 53 (3.77%)
occurrences all number	0	1	1	1	0	2
Covid-19
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	2 / 41 (4.88%)	1 / 7 (14.29%)	1 / 29 (3.45%)	3 / 53 (5.66%)
occurrences all number	1	1	2	1	1	3
Cellulitis
subjects affected / exposed	1 / 52 (1.92%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	2 / 29 (6.90%)	1 / 53 (1.89%)
occurrences all number	2	1	0	0	2	1
Upper respiratory tract infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	2 / 29 (6.90%)	3 / 53 (5.66%)
occurrences all number	0	0	0	1	2	4
Ear infection
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	2 / 41 (4.88%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	0	1	2	0	0	1
Bronchitis
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	3 / 53 (5.66%)
occurrences all number	0	0	1	0	0	3
Localised infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	2 / 29 (6.90%)	0 / 53 (0.00%)
occurrences all number	0	0	0	0	2	0
Oral candidiasis
subjects affected / exposed	2 / 52 (3.85%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	1 / 29 (3.45%)	4 / 53 (7.55%)
occurrences all number	2	0	2	0	1	5
Nasopharyngitis
subjects affected / exposed	2 / 52 (3.85%)	1 / 6 (16.67%)	1 / 41 (2.44%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	2	1	1	0	0	0
Stoma site infection
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	3	0	0	0	0	1
Lower respiratory tract infection
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Device related infection
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	1 / 53 (1.89%)
occurrences all number	1	0	0	1	0	1
Furuncle
subjects affected / exposed	0 / 52 (0.00%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	0	0	1	0	0
Metabolism and nutrition disorders
Hypocalcaemia
subjects affected / exposed	5 / 52 (9.62%)	0 / 6 (0.00%)	2 / 41 (4.88%)	0 / 7 (0.00%)	1 / 29 (3.45%)	2 / 53 (3.77%)
occurrences all number	5	0	2	0	3	2
Hypercalcaemia
subjects affected / exposed	5 / 52 (9.62%)	0 / 6 (0.00%)	1 / 41 (2.44%)	0 / 7 (0.00%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences all number	6	0	2	0	1	1
Hypomagnesaemia
subjects affected / exposed	10 / 52 (19.23%)	1 / 6 (16.67%)	4 / 41 (9.76%)	2 / 7 (28.57%)	8 / 29 (27.59%)	8 / 53 (15.09%)
occurrences all number	12	1	7	2	15	12
Hypoalbuminaemia
subjects affected / exposed	3 / 52 (5.77%)	0 / 6 (0.00%)	5 / 41 (12.20%)	0 / 7 (0.00%)	4 / 29 (13.79%)	4 / 53 (7.55%)
occurrences all number	3	0	5	0	7	7
Decreased appetite
subjects affected / exposed	14 / 52 (26.92%)	3 / 6 (50.00%)	10 / 41 (24.39%)	3 / 7 (42.86%)	3 / 29 (10.34%)	10 / 53 (18.87%)
occurrences all number	15	3	12	3	3	11
Hypophosphataemia
subjects affected / exposed	6 / 52 (11.54%)	3 / 6 (50.00%)	5 / 41 (12.20%)	0 / 7 (0.00%)	8 / 29 (27.59%)	2 / 53 (3.77%)
occurrences all number	6	3	5	0	10	2
Hypokalaemia
subjects affected / exposed	7 / 52 (13.46%)	1 / 6 (16.67%)	6 / 41 (14.63%)	0 / 7 (0.00%)	6 / 29 (20.69%)	10 / 53 (18.87%)
occurrences all number	9	1	6	0	13	11
Dehydration
subjects affected / exposed	0 / 52 (0.00%)	2 / 6 (33.33%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	2	0	1	0	0
Hyponatraemia
subjects affected / exposed	7 / 52 (13.46%)	2 / 6 (33.33%)	6 / 41 (14.63%)	1 / 7 (14.29%)	8 / 29 (27.59%)	9 / 53 (16.98%)
occurrences all number	10	3	8	2	11	13
Hyperglycaemia
subjects affected / exposed	1 / 52 (1.92%)	2 / 6 (33.33%)	6 / 41 (14.63%)	0 / 7 (0.00%)	1 / 29 (3.45%)	1 / 53 (1.89%)
occurrences all number	2	2	6	0	1	1
Failure to thrive
subjects affected / exposed	0 / 52 (0.00%)	1 / 6 (16.67%)	0 / 41 (0.00%)	0 / 7 (0.00%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	0	1	0	0	0	0
Iron deficiency
subjects affected / exposed	1 / 52 (1.92%)	0 / 6 (0.00%)	0 / 41 (0.00%)	1 / 7 (14.29%)	0 / 29 (0.00%)	0 / 53 (0.00%)
occurrences all number	1	0	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

12 Mar 2021

Herein is a summary of the major changes made to the original protocol dated 22 January 2021 and reflected in Amendment 1 dated 12 March 2021. The protocol has been amended to address feedback received from the FDA. The sections revised are as follows: For all safety run-in cohorts, modify the exceptions to dose-limiting toxicity (DLT) definition for neutropenia, thrombocytopenia, electrolyte abnormalities, nausea, vomiting, diarrhea, tumor flare phenomenon, tumor lysis and hypomagnesemia. For all safety run-in cohorts, incorporate Hy’s law criteria in the DLT definition for liver enzymes. Add criteria for dose delay and permanent discontinuation for magrolimab. Modify SAE reporting requirements after the protocol-defined follow-up period.

17 Mar 2021

Herein is a summary of the major changes made to Amendment 1 dated 12 March 2021 and reflected in Amendment 2 dated 17 March 2021. The protocol has been amended to address feedback received from the FDA. The sections revised are as follows: Modify the exceptions to dose-limiting toxicity (DLT) definition for transaminase elevations for all safety run-in cohorts. Modify and provide additional guidance for dose modifications and delays for magrolimab.

16 Dec 2021

The major update(s) to the protocol and related rationale are as follows: An additional Phase 2 treatment arm was added that includes zimberelimab to allow the assessment of the efficacy and safety of magrolimab in combination with pembrolizumab +platinum + 5-FU (Cohort 1 Arm A) versus pembrolizumab + platinum + 5-FU (Cohort 1 Arm B) versus zimberelimab + platinum + 5-FU (Cohort 1 Arm C). Arm C was added to provide a comparison of zimberelimab with pembrolizumab in combination with magrolimab and chemotherapeutics in the treatment of head and neck squamous cell carcinoma (HNSCC). )

26 Jan 2022

The major updates to the protocol and related rationale are as follows: Inclusion Criteria was revised to update the hemoglobin level requirement from ≥ 9.5 g/dL at screening to ≥ 9 g/dL within 24 hours prior to dosing. This is supplemented with hemoglobin monitoring after magrolimab infusion to ensure adequate hemoglobin levels and transfusion guidelines for all patients. Dosage and Administration of Magrolimab and Safety Assessments were updated to link to postinfusion hemoglobin reporting requirements detailed in . Type and Screen and Direct Antiglobulin Test was updated to emphasize that the results must be available before the first dose of magrolimab. Type and Screen and Direct Antiglobulin Test was added to support the instructions for toxicity management related to anemia. Anemia management described in was updated to clarify the risk of anemia in the first 2 weeks of treatment and to provide additional guidance for enhanced anemia management. The pregnancy reporting period for patients who receive treatment with zimberelimab has been updated to 120 days from 90 days in response to input from the FDA on a different study.

20 Sep 2022

The major updates to the protocol and related rationale are as follows:  Inclusion criteria (IC) and exclusion criteria (EC) were updated to add IC 16c (clarification to prior therapy requirements for Safety Run-in 2 and Phase 2 Cohort 3) and EC 8a (recommendation for testing of dihydropyrimidine dehydrogenase activity for patients in Phase 2 Cohort 1) Dosing instructions were updated. Clarifications to safety monitoring and laboratory assessments were made. Changes were made to Appendix 2 Schedule of Assessments. Appendix Table 2 was updated to clarify that visit may be conducted by telephone or in person. Appendix 5 was updated to update contraceptive requirements. Appendix 12 (Country-specific Considerations for France) was added to summarize updates made in the protocol to incorporate feedback received from the France health authority.

01 Nov 2023

Nonclinical and clinical experience with zimberelimab was added to provide a rationale for the use of zimberelimab in Cohort 1 Arm C. Objectives and endpoints were modified to indicate that disease progression will be determined by investigator assessment instead of independent central review. Instructions outlining the duration of postinfusion monitoring of patients after zimberelimab infusion have been added to align with the pharmacy instructions for zimberelimab. Instructions on the administration of docetaxel have been added to allow for the infusion duration to follow local practice. The benefit/risk assessment of the study was updated with potential overlapping toxicities and their mitigation per the current clinical experience with magrolimab. New sections for management of severe neutropenia and serious infections have been added. Cross-references to these sections have been added for further clarity on magrolimab dose delays with regards to these adverse events.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Laboratory Abnormalities According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Primary: Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Laboratory Abnormalities According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Primary: Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)

Primary: Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)

Primary: Phase 2 Cohort 3: Objective Response Rate (ORR)

Primary: Phase 2 Cohort 3: Objective Response Rate (ORR)

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab

Secondary: Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab

Secondary: Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)

Secondary: Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)

Secondary: Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)

Secondary: Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)

Secondary: Phase 2 Cohort 3: Progression-free Survival (PFS)

Secondary: Phase 2 Cohort 3: Progression-free Survival (PFS)

Secondary: All Phase 2 Cohorts: Duration of Response (DOR)

Secondary: All Phase 2 Cohorts: Duration of Response (DOR)

Secondary: All Phase 2 Cohorts: Overall Survival (OS)

Secondary: All Phase 2 Cohorts: Overall Survival (OS)

Secondary: Phase 2 Cohorts: Change from Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score

Secondary: Phase 2 Cohorts: Change from Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score

Secondary: Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H and N35)

Secondary: Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H and N35)

Secondary: Phase 2 Cohorts: Number of Participants with 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score

Secondary: Phase 2 Cohorts: Number of Participants with 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score

Secondary: Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score

Secondary: Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2 Study of Magrolimab Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma