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Clinical Trial Results:
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Summary
EudraCT number	2020-002829-28
Trial protocol	BE NL
Global end of trial date	28 Oct 2024

Results information
Results version number	v1(current)
This version publication date	31 Oct 2025
First version publication date	31 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

B8011011

ISRCTN number

US NCT number

NCT04585815

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

66 Hudson Boulevard East, New York, United States, NY 10001

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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

07 Mar 2025

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 Oct 2024

Was the trial ended prematurely?

Yes

Main objective of the trial

Substudy A (SSA): 1- To assess the dose limiting toxicity (DLT) rate and estimate the maximum tolerated dose (MTD) of sasanlimab in combination with encorafenib and binimetinib to determine the recommended Phase 2 dose (RP2D) for the combination. 2- To assess the durable objective response rate (ORR) of sasanlimab in combination with encorafenib and binimetinib. Substudy B (SSB): 1-) To assess the DLT rate and estimate the MTD of sasanlimab in combination with axitinib and SEATGT to determine the RP2D for the combination. 2-) To assess the ORR of sasanlimab in combination with axitinib and SEATGT.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Nov 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 23

Country: Number of subjects enrolled

Belgium: 1

Country: Number of subjects enrolled

Taiwan: 4

Country: Number of subjects enrolled

Australia: 6

Worldwide total number of subjects

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Sub-study A (SSA) was planned to be conducted in 2 parts: Phase 1b and Phase 2. Due to a business decision, Phase 2 was not initiated, hence no participants were enrolled for Phase 2 of SSA. Sub-study B (SSB) was conducted in 2 parts: Phase 1b and Phase 2.

Screening details

57 participants signed informed consent and 34 participants were enrolled in the study. Of these 34 participants, 13 were enrolled in Sub-study A and 21 in Sub-study B (9 in Phase [Ph] 1b and 12 in Phase 2).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Blinding implementation details

There was no blinding.

Are arms mutually exclusive

Yes

Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)

Arm description

Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 300 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 300 mg administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

Binimetinib 45 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Binimetinib 45 mg orally twice daily.

Investigational medicinal product name

Encorafenib 300 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received Encorafenib 300 mg orally once daily.

Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)

Arm description

Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 300 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 300 mg administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

Binimetinib 45 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Binimetinib 45 mg orally twice daily.

Investigational medicinal product name

Encorafenib 450 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received Encorafenib 450 mg orally once daily.

Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)

Arm description

Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Axitinib 5mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Axitinib 5mg orally twice daily.

Investigational medicinal product name

Sasanlimab 225 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 225 mg Q3W administered subcutaneously on Day 1 of each cycle.

Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)

Arm description

Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 225 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 225 mg Q3W administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

SEA-TGT 1 mg/kg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received a single dose of SEA-TGT 1 mg/kg administered intravenously on Day 1 of each cycle.

Investigational medicinal product name

Axitinib 5mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Axitinib 5mg orally twice daily.

Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Arm description

Participants with NSCLC who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 225 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 225 mg Q3W administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

SEA-TGT 1 mg/kg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received a single dose of SEA-TGT 1 mg/kg administered intravenously on Day 1 of each cycle.

Investigational medicinal product name

Axitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Axitinib 5mg orally twice daily.

Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Arm description

Participants with NSCLC who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to [>=]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA + TGT on Day 1 of each cycle during each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 225 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 225 mg Q3W administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

Axitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Axitinib 5mg orally twice daily.

Investigational medicinal product name

SEA-TGT 1 mg/kg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received a single dose of SEA-TGT 1 mg/kg administered intravenously on Day 1 of each cycle.

Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Arm description

Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS >= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Sasanlimab 225 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received a single dose of sasanlimab 225 mg Q3W administered subcutaneously on Day 1 of each cycle.

Investigational medicinal product name

SEA-TGT 1 mg/kg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received a single dose of SEA-TGT 1 mg/kg administered intravenously on Day 1 of each cycle.

Investigational medicinal product name

Axitinib 5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received Axitinib 5mg orally twice daily.

Number of subjects in period 1	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Started	4	9	3	6	3	2	7
Completed	0	0	0	0	0	0	0
Not completed	4	9	3	6	3	2	7
Adverse event, serious fatal	-	2	-	1	-	-	-
Consent withdrawn by subject	1	-	-	1	-	1	-
Physician decision	-	-	-	1	1	-	-
Global deterioration of health status	-	1	-	1	-	-	-
Adverse event, non-fatal	1	4	-	-	-	-	2
Study terminated by sponsor	1	1	-	-	-	-	-
Unspecified	1	-	-	-	-	-	-
Progressive disease	-	1	3	2	2	1	5

Baseline characteristics

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Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)

Reporting group description

Reporting group title

Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group title

Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group title

Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Total
Number of subjects	4	9	3	6	3	2	7	34
Age categorical
Units: Subjects
In Utero	0	0	0	0	0	0	0	0
Preterm newborn infants (gestional age < 37 wks)	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0
Infants and toddlers (28 days - 23 months)	0	0	0	0	0	0	0	0
Children (2 - 11 years)	0	0	0	0	0	0	0	0
12 - 17 years	0	0	0	0	0	0	0	0
Adults (18 - 64 years)	1	5	0	1	1	0	5	13
From 65 - 84 years	3	4	3	5	2	2	2	21
85 years and over	0	0	0	0	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	67.50 ( 8.74 )	61.56 ( 8.66 )	68.33 ( 1.53 )	69.50 ( 7.34 )	69.33 ( 7.51 )	67.50 ( 2.12 )	62.57 ( 7.07 )	-
Gender categorical
Units: Subjects
Male	1	6	2	5	2	1	5	22
Female	3	3	1	1	1	1	2	12
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	1	0	0	0	0	1	2
Not Hispanic or Latino	4	8	3	6	3	2	6	32
Unknown or Not Reported	0	0	0	0	0	0	0	0
Race (NIH/OMB)
Units: Subjects
Black or African American	1	0	0	2	1	0	0	4
Asian	1	5	0	1	0	0	0	7
White	2	4	3	3	2	2	7	23

End points

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Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)

Reporting group description

Reporting group title

Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group title

Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group title

Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Primary: Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)

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End point title

Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT) ^[1] ^[2]

End point description

DLT=AEs in DLT observation period(OP) related to any study intervention: Grade(G)4 neutropenia;thrombocytopenia/ anemia; febrile neutropenia; neutropenic infection;G3 thrombocytopenia with bleeding. Any G>=3 toxicity (except transient G3 fatigue, local reactions/ headache that resolved to G<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by medical therapy [MT], G3 diarrhea that improved to G<=2 within 72 hrs,G3 skin toxicity that resolved to G<=1 in <7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 lab abnormality [LA]/ any G4 LA;ALT/AST>3*ULN (normal at baseline) or >3*ULN and doubling baseline (>ULN at baseline) and associated with total bilirubin(TB) >2*ULN; or ALT/AST >5*ULN; or TB>3*ULN. DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and eitherexperienced DLT during DLT-observation period/ completed DLT-observation period without DLT.

End point type

Primary

End point timeframe

Day 1 up to Day 28 of Cycle 1

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 analyses have been planned
[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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Percentage of participants
number (not applicable)	0	33.3

No statistical analyses for this end point

Primary: Phase 1b of Sub-Study B: Percentage of Participants With DLT

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End point title

Phase 1b of Sub-Study B: Percentage of Participants With DLT ^[3] ^[4]

End point description

DLT=AEs in DLT OP related to any study intervention: Grade(G)4 neutropenia; thrombocytopenia/ anemia; febrile neutropenia; neutropenic infection; G3 thrombocytopenia with bleeding. Any G>=3 toxicity (except transient G3 fatigue, local reactions/ headache that resolved to G<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by MT, G3 diarrhea that improved to G<=2 within 72 hrs,G3 skin toxicity that resolved to G<=1 in <7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 LA/ any G4 LA;ALT/AST>3*ULN (normal at baseline) or >3*ULN and doubling baseline (>ULN at baseline) and associated with total bilirubin >2*ULN; or ALT/ AST >5*ULN; or TB>3*ULN. DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and either experienced DLT during DLT-observation period/ completed DLT-observation period without DLT.

End point type

Primary

End point timeframe

Day 1 up to Day 21 of Cycle 1

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 analyses have been planned
[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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Percentage of participants
number (not applicable)	0	16.7

No statistical analyses for this end point

Primary: Phase 2 Sub-Study B: Objective Response Rate

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End point title

Phase 2 Sub-Study B: Objective Response Rate ^[5] ^[6]

End point description

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Notes
[5] - 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 analyses have been planned
[6] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Percentage of participants
median (confidence interval 95%)	33.3 (0.8 to 90.6)	0.0 (0.0 to 84.2)	14.3 (0.4 to 57.9)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

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End point title

Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 ^[7]

End point description

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs was graded by the investigator according to NCI CTCAE grade 1 to 5 version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death. Safety analysis set includes all participants who receive at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

Notes
[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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Participants
Grade 1	1	0
Grade 2	0	2
Grade 3	3	4
Grade 4	0	2
Grade 5	0	1

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

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End point title

Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0 ^[8]

End point description

Hematology parameters included: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, leukocytosis, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) with non-zero values were reported. Safety analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Participants
Anemia: Grade 0 to 0	3	2
Anemia: Grade 0 to 1	0	2
Anemia: Grade 0 to 2	0	1
Anemia: Grade 1 to 1	0	4
Anemia: Grade 1 to 2	1	0
Hemoglobin increased: Grade 0 to 0	4	8
Hemoglobin increased: Grade 0 to 1	0	1
Leukocytosis: Grade 0 to 0	4	9
Lymphocyte count decreased: Grade 0 to 0	2	3
Lymphocyte count decreased: Grade 0 to 1	1	1
Lymphocyte count decreased: Grade 0 to 2	1	2
Lymphocyte count decreased: Grade 0 to 4	0	1
Lymphocyte count decreased: Grade 1 to 2	0	1
Lymphocyte count decreased: Grade 2 to 2	0	1
Lymphocyte count increased: Grade 0 to 0	4	9
Neutrophil count decreased: Grade 0 to 0	4	7
Neutrophil count decreased: Grade 0 to 1	0	1
Neutrophil count decreased: Grade 0 to 2	0	1
Platelet count decreased: Grade 0 to 0	4	7
Platelet count decreased: Grade 0 to 1	0	1
Platelet count decreased: Grade 1 to 1	0	1
White blood cell decreased: Grade 0 to 0	3	8
White blood cell decreased: Grade 0 to 1	1	0
White blood cell decreased: Grade 2 to 2	0	1

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

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End point title

Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0 ^[9]

End point description

Chemistry parameters included: alanine aminotransferase (ALT) increase, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine phosphokinase (CPK) increased, chronic kidney disease (CKD), creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Chemistry abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in chemistry parameters by grades (as per CTCAE version 5.0) with non-zero values were reported. Safety analysis set.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

Notes
[9] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Participants
Alanine aminotransferase increased: Grade 0 to 0	2	2
Alanine aminotransferase increased: Grade 0 to 1	2	2
Alanine aminotransferase increased: Grade 0 to 2	0	2
Alanine aminotransferase increased: Grade 0 to 3	0	3
Alkaline phosphatase increased: Grade 0 to 0	1	3
Alkaline phosphatase increased: Grade 0 to 1	0	2
Alkaline phosphatase increased: Grade 0 to 2	0	1
Alkaline phosphatase increased: Grade 1 to 0	2	2
Alkaline phosphatase increased: Grade 1 to 2	1	0
Aspartate aminotransferase increased:Grade0 to 0	2	2
Aspartate aminotransferase increased:Grade0 to 1	2	4
Aspartate aminotransferase increased:Grade0 to 2	0	1
Aspartate aminotransferase increased:Grade0 to 3	0	1
Aspartate aminotransferase increased:Grade1 to 2	0	1
Blood bilirubin increased: Grade 0 to 0	4	8
Blood bilirubin increased: Grade 0 to 3	0	1
CPK increased: Grade 0 to 0	2	4
CPK increased: Grade 0 to 1	2	1
CPK increased: Grade 0 to 2	0	2
CPK increased: Grade 0 to 3	0	1
CPK increased: Grade 0 to 4	0	1
Chronic kidney disease: Grade 0 to 0	1	3
Chronic kidney disease: Grade 0 to 1	0	1
Chronic kidney disease: Grade 0 to 2	2	3
Chronic kidney disease: Grade 1 to 1	1	1
Chronic kidney disease: Grade 2 to 2	0	1
Creatinine increased: Grade 0 to 0	1	6
Creatinine increased: Grade 0 to 1	2	2
Creatinine increased: Grade 0 to 2	1	1
Hypercalcemia: Grade 0 to 0	3	4
Hypercalcemia: Grade 0 to 1	1	5
Hyperkalemia: Grade 0 to 0	4	8
Hyperkalemia: Grade 0 to 1	0	1
Hypermagnesemia: Grade 0 to 0	4	8
Hypermagnesemia: Grade 0 to 1	0	1
Hypernatremia: Grade 0 to 0	4	8
Hypernatremia: Grade 0 to 1	0	1
Hypoalbuminemia: Grade 0 to 0	2	3
Hypoalbuminemia: Grade 0 to 1	1	3
Hypoalbuminemia: Grade 0 to 2	0	1
Hypoalbuminemia: Grade 0 to 3	1	0
Hypoalbuminemia: Grade 1 to 1	0	1
Hypoalbuminemia: Grade 1 to 2	0	1
Hypocalcemia: Grade 0 to 0	4	7
Hypocalcemia: Grade 0 to 1	0	2
Hypoglycemia: Grade 0 to 0	4	7
Hypoglycemia: Grade 0 to 1	0	1
Hypoglycemia: Grade 1 to 0	0	1
Hypokalemia: Grade 0 to 0	4	7
Hypokalemia: Grade 0 to 2	0	1
Hypokalemia: Grade 0 to 3	0	1
Hypomagnesemia: Grade 0 to 0	4	8
Hypomagnesemia: Grade 0 to 1	0	1
Hyponatremia: Grade 0 to 0	3	5
Hyponatremia: Grade 0 to 1	0	1
Hyponatremia: Grade 0 to 3	0	1
Hyponatremia: Grade 1 to 0	1	0
Hyponatremia: Grade 1 to 3	0	2
Lipase increased: Grade 0 to 0	1	5
Lipase increased: Grade 0 to 1	2	3
Lipase increased: Grade 0 to 2	1	1
Serum amylase increased: Grade 0 to 0	4	7
Serum amylase increased: Grade 0 to 3	0	1
Serum amylase increased: Grade 1 to 1	0	1

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Durable Objective Response Rate (ORR)

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End point title

Phase 1b of Sub-Study A: Durable Objective Response Rate (ORR) ^[10]

End point description

Durable ORR was defined as percentage of participants with confirmed CR/ PR according to RECIST v1.1 based on investigator assessment, lasting for at least 10 months from date of first CR/ PR until date of first documentation of PD, death/ start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 milli meter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum is observed during therapy) with minimum absolute increase of 5 mm. Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level (if being followed) above normal limits. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 38.66 months)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Percentage of Participants
number (confidence interval 95%)	25.0 (0.6 to 80.6)	44.4 (13.7 to 78.8)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

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End point title

Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab ^[11]

End point description

AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose. Pharmacokinetic (PK) parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, “Subject Analyzed” (N) signifies participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	3	7
Units: Micrograms*hour per millilitre
geometric mean (geometric coefficient of variation)	12500 ( 65 )	24850 ( 17 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab

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End point title

Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab ^[12]

End point description

End point type

Secondary

End point timeframe

Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Micrograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=4,9)	29.49 ( 55 )	45.04 ( 38 )
Cycle 5 (n=1,1)	64.60 ( 99999 )	70.90 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Objective Response Rate

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End point title

Phase 1b of Sub-Study A: Objective Response Rate ^[13]

End point description

Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level (if being followed) above the normal limits. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 38.66 months)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Percentage of Participants
number (confidence interval 95%)	50.0 (6.8 to 93.2)	44.4 (13.7 to 78.8)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Ctrough of Encorafenib

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End point title

Phase 1b of Sub-Study A: Ctrough of Encorafenib ^[14]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "n" signifies participants evaluable at specified timepoints. "99999"= data could not be calculated as values were below lower limit of quantification. "88888" = samples were not analyzed for Cycle 2 Day 1 as it was collected incorrectly due to time deviation for visits. "77777"= Geometric coefficient of variation could not be calculated for single participant

End point type

Secondary

End point timeframe

Day 1 (pre-dose) of Cycle 1, 2 and 5; Day 15 of Cycle 1 (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=4,9)	99999 ( 99999 )	99999 ( 99999 )
Cycle 1 Day 15 (n=2,4)	12.2 ( 176 )	18.5 ( 50 )
Cycle 2 Day 1 (n=0,4)	88888 ( 88888 )	11.1 ( 204 )
Cycle 5 Day 1 (n=1,2)	5.0 ( 77777 )	7.8 ( 191 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab

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End point title

Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab ^[15]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). "99999"= Median and full range could not be calculated as only 1 participant was analyzed. Here, "n" signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Hours
median (full range (min-max))
Cycle 1 (n=4,9)	164 (144 to 168)	209 (143 to 359)
Cycle 5 (n=1,1)	99999 (-99999 to 99999)	99999 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

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End point title

Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab ^[16]

End point description

End point type

Secondary

End point timeframe

Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	3	2
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)	37.97 ( 20 )	40.24 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Ctrough of Binimetinib

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End point title

Phase 1b of Sub-Study A: Ctrough of Binimetinib ^[17]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, Subject Analyzed signifies participants evaluable for this endpoint. "99999"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "88888" = Geometric coefficient of variation could not be calculated for single participant. "n" signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Day 1 (pre-dose) of Cycles 1, 2, and 5 (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	1	4
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=0,0)	99999 ( 99999 )	99999 ( 99999 )
Cycle 2 Day 1 (n=1,4)	19.2 ( 88888 )	40.9 ( 98 )
Cycle 5 Day 1 (n=0,3)	99999 ( 99999 )	35.7 ( 67 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab

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End point title

Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab ^[18]

End point description

In this endpoint, number of ADA-positive and NAb-positive participants has been presented. A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted). Immunogenicity analysis set was a subset of the safety analysis set (participants who received at least 1 dose of study drug) and included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. All participants included in ‘Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, ‘n’ signifies participants evaluated for ADA and NAb respectively.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days) (1 cycle= 28 days)

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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)
Number of subjects analysed	4	9
Units: Participants
ADA (n=4,7)	0	1
NAb (n=4,6)	0	0

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

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End point title

Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 ^[19]

End point description

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death. Safety analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[19] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Participants
Grade 1	0	0
Grade 2	1	0
Grade 3	2	4
Grade 4	0	1
Grade 5	0	1

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

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End point title

Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 ^[20]

End point description

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[20] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Participants
Grade 1	0	0	1
Grade 2	0	0	2
Grade 3	2	2	2
Grade 4	1	0	2
Grade 5	0	0	0

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

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End point title

Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0 ^[21]

End point description

Hematology parameters included: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) with non-zero values were reported. Safety analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[21] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Participants
Anemia (Grade 0 to 0)	0	2
Anemia (Grade 0 to 1)	1	0
Anemia (Grade 1 to 1)	2	3
Anemia (Grade 2 to 2)	0	1
Hemoglobin increased (Grade 0 to 0)	3	6
Leukocytosis (Grade 0 to 0)	3	6
Lymphocyte count decreased (Grade 0 to 0)	1	1
Lymphocyte count decreased (Grade 0 to 2)	0	1
Lymphocyte count decreased (Grade 0 to 3)	0	1
Lymphocyte count decreased (Grade 0 to 4)	0	1
Lymphocyte count decreased (Grade 1 to 2)	2	0
Lymphocyte count decreased (Grade 1 to 4)	0	1
Lymphocyte count decreased (Grade 2 to 2)	0	1
Lymphocyte count increased (Grade 0 to 0)	3	6
Neutrophil count decreased (Grade 0 to 0)	3	6
Platelet count decreased (Grade 0 to 0)	2	5
Platelet count decreased (Grade 0 to 1)	1	1
White blood cell decreased (Grade 0 to 0)	3	5
White blood cell decreased (Grade 0 to 1)	0	1

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

Top of page

End point title

Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0 ^[22]

End point description

Chemistry parameters included: alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine phosphokinase (CPK) increased, chronic kidney disease (CKD), creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Chemistry abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in chemistry parameters by grades (as per CTCAE version 5.0) with non-zero values were reported. Safety analysis set used.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[22] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Participants
ALT increased (Grade 0 to 0)	1	5
ALT increased (Grade 0 to 1)	2	0
ALT increased (Grade 0 to 2)	0	1
ALP increased (Grade 0 to 0)	2	4
ALP increased (Grade 0 to 1)	0	2
ALP increased (Grade 1 to 2)	1	0
AST increased (Grade 0 to 0)	0	5
AST increased (Grade 0 to 1)	1	0
AST increased (Grade 0 to 3)	0	1
AST increased (Grade 1 to 0)	1	0
AST increased (Grade 1 to 1)	1	0
Blood bilirubin increased (Grade 0 to 0)	3	6
CPK increased (Grade 0 to 0)	3	5
CPK increased (Grade 1 to 0)	0	1
Chronic kidney disease (Grade 0 to 0)	1	0
Chronic kidney disease (Grade 0 to 1)	1	2
Chronic kidney disease (Grade 0 to 2)	0	1
Chronic kidney disease (Grade 1 to 2)	0	1
Chronic kidney disease (Grade 2 to 2)	1	2
Creatinine increased (Grade 0 to 0)	2	3
Creatinine increased (Grade 1 to 1)	1	2
Creatinine increased (Grade 1 to 2)	0	1
Hypercalcemia (Grade 0 to 0)	1	5
Hypercalcemia (Grade 0 to 1)	2	1
Hyperkalemia (Grade 0 to 0)	2	5
Hyperkalemia (Grade 0 to 1)	1	1
Hypermagnesemia (Grade 0 to 0)	3	6
Hypernatremia (Grade 0 to 0)	3	6
Hypoalbuminemia (Grade 0 to 0)	2	2
Hypoalbuminemia (Grade 0 to 1)	1	1
Hypoalbuminemia (Grade 0 to 2)	0	1
Hypoalbuminemia (Grade 1 to 2)	0	1
Hypoalbuminemia (Grade 2 to 2)	0	1
Hypocalcemia (Grade 0 to 0)	3	6
Hypoglycemia (Grade 0 to 0)	2	5
Hypoglycemia (Grade 0 to 1)	1	1
Hypokalemia (Grade 0 to 0)	2	4
Hypokalemia (Grade 0 to 2)	1	2
Hypomagnesemia (Grade 0 to 0)	1	5
Hypomagnesemia (Grade 0 to 1)	1	1
Hypomagnesemia (Grade 2 to 1)	0	1
Hyponatremia (Grade 0 to 0)	2	4
Hyponatremia (Grade 0 to 1)	1	2
Lipase increased (Grade 0 to 0)	3	4
Lipase increased (Grade 0 to 1)	0	2
Serum amylase increased (Grade 0 to 0)	3	4
Serum amylase increased (Grade 0 to 1)	0	1
Serum amylase increased (Grade 1 to 2)	0	1

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0

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End point title

Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 ^[23]

End point description

Hematology parameters included: anemia, hemoglobin increased, lymphocyte count decreased and increased, leukocytosis, neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with shift from baseline in hematology parameters by grades as per CTCAE version 5.0 with non-zero values were reported. Grade 0= non-missing lab value that does not meet either of Grade 1 through 4 criteria; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Safety analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[23] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Participants
Anemia (Grade 0 to 0)	1	0	5
Anemia (Grade 0 to 1)	1	0	0
Anemia (Grade 1 to 0)	0	0	1
Anemia (Grade 1 to 1)	0	2	1
Anemia (Grade 2 to 2)	1	0	0
Hemoglobin increased (Grade 0 to 0)	3	2	6
Hemoglobin increased (Grade 0 to 1)	0	0	1
Leukocytosis (Grade 0 to 0)	3	2	7
Lymphocyte count decreased (Grade 0 to 0)	0	0	3
Lymphocyte count decreased (Grade 0 to 2)	0	0	2
Lymphocyte count decreased (Grade 0 to 3)	1	1	0
Lymphocyte count decreased (Grade 1 to 2)	0	1	0
Lymphocyte count decreased (Grade 1 to 3)	1	0	1
Lymphocyte count decreased (Grade 2 to 4)	1	0	0
Lymphocyte count decreased (Grade 3 to 4)	0	0	1
Lymphocyte count increased (Grade 0 to 0)	3	2	7
Neutrophil count decrease (Grade 0 to 0)	2	2	7
Neutrophil count decrease (Grade 0 to 2)	1	0	0
Platelet count decreased (Grade 0 to 0)	2	2	6
Platelet count decreased (Grade 0 to 2)	1	0	1
White blood Cell decreased (Grade 0 to 0)	1	1	5
White blood Cell decreased (Grade 0 to 1)	1	0	2
White blood Cell decreased (Grade 0 to 3)	1	0	0
White blood Cell decreased (Grade 1 to 1)	0	1	0

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0

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End point title

Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ^[24]

End point description

Chemistry parameters included: ALT increased, ALP increased, AST increased, blood bilirubin increased, chronic kidney disease, CPK increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Number of participants with maximum CTCAE V5.0 grade in chemistry parameters with non-zero values were reported. Grade 0= non-missing lab value that does not meet either of Grade 1 through 4 criteria; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Safety analysis set included all participants who received at least 1 dose of study drug. Here, "n" signifies number of participants evaluable for the specified rows.

End point type

Secondary

End point timeframe

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months)

Notes
[24] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Participants
ALT increased: Grade 0 to 0 (n=3,2,7)	1	1	3
ALT increased: Grade 0 to 1 (n=3,2,7)	1	0	3
ALT increased: Grade 0 to 3 (n=3,2,7)	1	1	0
ALT increased: Grade 0 to 4 (n=3,2,7)	0	0	1
ALP increased: Grade 0 to 0 (n=3,2,7)	0	1	3
ALP increased: Grade 0 to 1 (n=3,2,7)	2	1	2
ALP increased: Grade 1 to 0 (n=3,2,7)	1	0	2
AST increased: Grade 0 to 0 (n=3,2,7)	1	1	2
AST increased: Grade 0 to 1 (n=3,2,7)	1	0	4
AST increased: Grade 0 to 3 (n=3,2,7)	1	1	0
AST increased: Grade 0 to 4 (n=3,2,7)	0	0	1
Blood bilirubin increased: Grade 0 to 0 (n=3,2,7)	2	1	6
Blood bilirubin increased: Grade 0 to 1 (n=3,2,7)	1	1	0
Blood bilirubin increased: Grade 0 to 3 (n=3,2,7)	0	0	1
CPK increased: Grade 0 to 0 (n=3,2,6)	3	2	5
CPK increased: Grade 1 to 0 (n=3,2,6)	0	0	1
Chronic kidney disease: Grade 0 to 0 (n=3,2,7)	1	2	5
Chronic kidney disease: Grade 0 to 2 (n=3,2,7)	0	0	1
Chronic kidney disease: Grade 0 to 3 (n=3,2,7)	1	0	0
Chronic kidney disease: Grade 1 to 2 (n=3,2,7)	1	0	0
Chronic kidney disease: Grade 2 to 2 (n=3,2,7)	0	0	1
Creatinine increased: Grade 0 to 0 (n=3,2,7)	1	2	5
Creatinine increased: Grade 0 to 1 (n=3,2,7)	0	0	1
Creatinine increased: Grade 0 to 3 (n=3,2,7)	1	0	0
Creatinine increased: Grade 1 to 1 (n=3,2,7)	1	0	1
Hypercalcemia: Grade 0 to 0 (n=3,2,7)	2	2	7
Hypercalcemia: Grade 0 to 1 (n=3,2,7)	1	0	0
Hyperkalemia: Grade 0 to 0 (n=3,2,7)	2	1	6
Hyperkalemia: Grade 0 to 1 (n=3,2,7)	0	1	1
Hyperkalemia: Grade 0 to 2(n=3,2,7)	1	0	0
Hypermagnesemia: Grade 0 to 0 (n=3,2,7)	3	2	6
Hypermagnesemia: Grade 0 to 1 (n=3,2,7)	0	0	1
Hypernatremia: Grade 0 to 0 (n=3,2,7)	3	2	6
Hypernatremia: Grade 0 to 1 (n=3,2,7)	0	0	1
Hypoalbuminemia: Grade 0 to 0 (n=3,2,7)	1	2	4
Hypoalbuminemia: Grade 0 to 1 (n=3,2,7)	1	0	1
Hypoalbuminemia: Grade 0 to 2 (n=3,2,7)	1	0	2
Hypocalcemia: Grade 0 to 0 (n=3,2,7)	2	2	6
Hypocalcemia: Grade 0 to 1 (n=3,2,7)	1	0	0
Hypocalcemia: Grade 1 to 1 (n=3,2,7)	0	0	1
Hypoglycemia: Grade 0 to 0 (n=3,2,7)	3	2	7
Hypokalemia: Grade 0 to 0 (n=3,2,7)	2	1	4
Hypokalemia: Grade 0 to 2 (n=3,2,7)	0	1	2
Hypokalemia: Grade 0 to 3 (n=3,2,7)	1	0	0
Hypokalemia: Grade 2 to 2 (n=3,2,7)	0	0	1
Hypomagnesemia: Grade 0 to 0 (n=3,2,7)	2	2	3
Hypomagnesemia: Grade 0 to 1 (n=3,2,7)	0	0	4
Hypomagnesemia: Grade 0 to 2 (n=3,2,7)	1	0	0
Hyponatremia: Grade 0 to 0 (n=3,2,7)	2	1	4
Hyponatremia: Grade 0 to 1 (n=3,2,7)	1	0	0
Hyponatremia: Grade 0 to 3 (n=3,2,7)	0	0	3
Hyponatremia: Grade 1 to 3 (n=3,2,7)	0	1	0
Lipase increased: Grade 0 to 0 (n=3,2,7)	1	2	5
Lipase increased: Grade 0 to 1 (n=3,2,7)	2	0	0
Lipase increased: Grade 0 to 2 (n=3,2,7)	0	0	1
Lipase increased: Grade 0 to 3 (n=3,2,7)	0	0	1
Serum amylase increased: Grade 0 to 0 (n=3,2,7)	2	2	4
Serum amylase increased: Grade 0 to 1 (n=3,2,7)	1	0	1
Serum amylase increased: Grade 2 to 2 (n=3,2,7)	0	0	1
Serum amylase increased: Grade 2 to 3 (n=3,2,7)	0	0	1

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Duration of Response (DR)

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End point title

Phase 1b of Sub-Study B: Duration of Response (DR) ^[25]

End point description

DR was defined for participants with confirmed objective response (OR) as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.

End point type

Secondary

End point timeframe

From the date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)

Notes
[25] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	0 ^[26]	0 ^[27]
Units: Months
number (confidence interval 95%)	( to )	( to )

Notes
[26] - Data not estimable due to insufficient number of participants(with events) evaluable for endpoint.
[27] - Data not estimable due to insufficient number of participants(with events) evaluable for endpoint.

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Objective Response Rate

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End point title

Phase 1b of Sub-Study B: Objective Response Rate ^[28]

End point description

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Two sided 95% CI was based on Clopper-Pearson method. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurred first (maximum of 21 months)

Notes
[28] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 70.8)	0.0 (0.0 to 45.9)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Progression-Free Survival (PFS)

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End point title

Phase 1b of Sub-Study B: Progression-Free Survival (PFS) ^[29]

End point description

PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. Full analysis set included all participants who received at least 1 dose of study drug. "99999"= Data could not be calculated due to insufficient number of participants with event. Here, Subjects Analyzed signifies participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)

Notes
[29] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	5
Units: Months
median (confidence interval 95%)	3.6 (0.7 to 99999)	6.5 (3.6 to 99999)

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Time to Tumor Response (TTR)

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End point title

Phase 2 of Sub-Study B: Time to Tumor Response (TTR) ^[30]

End point description

TTR is defined for participants with confirmed OR as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Full analysis set included all participants who received at least 1 dose of study drug. "99999"= Median and full range could not be calculated as sonly 1 participant was analyzed. Here, Subjects Analyzed signifies participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)

Notes
[30] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	1	0 ^[31]	1
Units: Months
median (full range (min-max))	99999 (-99999 to 99999)	( to )	99999 (-99999 to 99999)

Notes
[31] - Data not estimable due to insufficient number of participants(with events) evaluable for endpoint.

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Duration of Response (DR)

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End point title

Phase 2 of Sub-Study B: Duration of Response (DR) ^[32]

End point description

DR: participants with confirmed OR as time from date of first documentation of OR to date of first documentation of PD/death (any cause), whichever occurred first. OR=CR/PR per RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all TLs with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater >= 30% decrease under baseline of sum of diameters of all TMLs. PD=20% increase in sum of diameters of TMLs above smallest sum observed, with minimum absolute increase of 5 mm. 99999= Median, 95% CI could not be calculated as only participant analyzed did not have an event of interest. 88888= 95% CI could not be calculated as 1 participant was analyzed, who experienced an event of interest. Full analysis set. N= participants evaluable for this endpoint and included only those participants with confirmed OR.

End point type

Secondary

End point timeframe

From date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)

Notes
[32] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	1	0 ^[33]	1
Units: Months
median (confidence interval 95%)	99999 (-99999 to 99999)	( to )	5.8 (-88888 to 88888)

Notes
[33] - No participant had confirmed OR

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Time to Tumor Response (TTR)

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End point title

Phase 1b of Sub-Study B: Time to Tumor Response (TTR) ^[34]

End point description

TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

End point type

Secondary

End point timeframe

From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)

Notes
[34] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	0 ^[35]	0 ^[36]
Units: Months
median (confidence interval 95%)	( to )	( to )

Notes
[35] - Data not estimable due to insufficient number of participants(with events) evaluable for endpoint.
[36] - Data not estimable due to insufficient number of participants(with events) evaluable for endpoint.

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Overall Survival (OS)

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End point title

Phase 2 of Sub-Study B: Overall Survival (OS) ^[37]

End point description

OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact. "99999" = Data could not be calculated due to insufficient participants with event. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)

Notes
[37] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Months
median (confidence interval 95%)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	4.0 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Progression-Free Survival (PFS)

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End point title

Phase 2 of Sub-Study B: Progression-Free Survival (PFS) ^[38]

End point description

PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. "99999" = Data could not be calculated due to insufficient participants with event. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)

Notes
[38] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Months
median (confidence interval 95%)	4.2 (4.0 to 99999)	99999 (-99999 to 99999)	4.0 (1.4 to 4.2)

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Cmax of Sasanlimab

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End point title

Phase 1b of Sub-Study B: Cmax of Sasanlimab ^[39]

End point description

End point type

Secondary

End point timeframe

Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[39] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	3
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=3,3)	8840 ( 127 )	11570 ( 79 )
Cycle 5 (n=2,3)	23080 ( 99999 )	47340 ( 42 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Cmax of SEA-TGT

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End point title

Phase 1b of Sub-Study B: Cmax of SEA-TGT ^[40]

End point description

PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Subjects Analyzed signifies participants evaluable for this endpoint. n= participants evaluable at specified timepoints. Data for only those participants who received SEA-TGT were planned to be reported for this outcome measure.

End point type

Secondary

End point timeframe

Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[40] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	5
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=5)	42550 ( 109 )
Cycle 5 (n=4)	32660 ( 17 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Cmax of Axitinib

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End point title

Phase 1b of Sub-Study B: Cmax of Axitinib ^[41]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[41] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	5
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=2, 5)	5.094 ( 99999 )	22.81 ( 80 )
Cycle 1 Day 8 (n=1,3)	3.440 ( 77777 )	13.74 ( 106 )
Cycle 5 Day 1 (n=0,4)	88888 ( 88888 )	33.79 ( 73 )
Cycle 5 Day 8 (n=1,2)	13.10 ( 77777 )	24.85 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Cmax of sasanlimab

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End point title

Phase 2 of Sub-Study B: Cmax of sasanlimab ^[42]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[42] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=3,2,7)	11780 ( 45 )	13810 ( 99999 )	10350 ( 45 )
Cycle 5 (n=0,1,1)	88888 ( 88888 )	43500 ( 77777 )	20600 ( 77777 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Cmax of axitinib

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End point title

Phase 2 of Sub-Study B: Cmax of axitinib ^[43]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[43] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	6
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=3,2,6)	37.43 ( 85 )	18.23 ( 99999 )	11.18 ( 112 )
Cycle 1 Day 8 (n=1,1,4)	39.50 ( 77777 )	2.360 ( 77777 )	2.708 ( 132 )
Cycle 5 Day 1 (n=0,1,1)	88888 ( 88888 )	11.10 ( 77777 )	7.710 ( 77777 )
Cycle 5 Day 8 (n=0,0,0)	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

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End point title

Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab ^[44]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 and Cycle 5 Day 1 (1 cycle= 21 days)

Notes
[44] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	2	4
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=0,0)	88888 ( 88888 )	88888 ( 88888 )
Cycle 5 (n=2,4)	23000 ( 99999 )	23170 ( 29 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Cmax of SEA-TGT

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End point title

Phase 2 of Sub-Study B: Cmax of SEA-TGT ^[45]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Notes
[45] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=3,2,7)	36970 ( 36 )	35500 ( 99999 )	30590 ( 39 )
Cycle 5 (n=0,1,1)	88888 ( 88888 )	43000 ( 77777 )	44900 ( 77777 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib

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End point title

Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib ^[46]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)

Notes
[46] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	1	3
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=0,0)	88888 ( 88888 )	88888 ( 88888 )
Cycle 1 Day 8 (n=1,3)	3.440 ( 77777 )	13.74 ( 106 )
Cycle 5 Day 1 (n=0,2)	88888 ( 88888 )	29.42 ( 99999 )
Cycle 5 Day 8 (n=1,2)	13.10 ( 77777 )	24.85 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT

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End point title

Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT ^[47]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Data for only those participants who received SEA-TGT were planned to be reported hence Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) arm was not reported. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)

Notes
[47] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	4
Units: Nanograms per milliliter
geometric mean (geometric coefficient of variation)
Cycle 1 (n=0)	88888 ( 88888 )
Cycle 5 (n=4)	4813 ( 35 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

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End point title

Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab ^[48]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "88888"= Geometric mean and geometric coefficient of variation could not be calculated as zero participants were analyzed. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints. This endpoint was not applicable for participants of ‘’Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%’’

End point type

Secondary

End point timeframe

Cycle 1: pre-dose on Day 1, Cycle 5: pre-dose on Day 1 (1 cycle= 21 days)

Notes
[48] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	1	2
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=0,2)	88888 ( 88888 )	87.01 ( 99999 )
Cycle 5 (n=1,1)	30400 ( 77777 )	20000 ( 77777 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib

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End point title

Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib ^[49]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)

Notes
[49] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	1 ^[50]	1	4
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=0,0,0)	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Cycle 1 Day 8 (n=1,1,4)	39.50 ( 77777 )	2.360 ( 77777 )	2.708 ( 132 )
Cycle 5 Day 1 (n=0,0,1)	88888 ( 88888 )	88888 ( 88888 )	3.630 ( 77777 )
Cycle 5 Day 8 (n=0,0,0)	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

Notes
[50] - This endpoint was not applicable for participants of ‘’Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%’’

No statistical analyses for this end point

Secondary: Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT

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End point title

Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ^[51]

End point description

A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted). Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. Here ‘’n’’ signifies number of participants with at least one post-treatment ADA result for respective category.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)

Notes
[51] - 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: The end point is reporting statistics for the arms specified

End point values	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Number of subjects analysed	3	6
Units: Participants
ADA against sasanlimab (n=3,6)	0	1
ADA against sasanlimab (n=0,6)	0	0

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT

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End point title

Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT ^[52]

End point description

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. "99999"= Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data. "77777" = Geometric coefficient of variation could not be calculated for single participant. Here, Subjects Analyzed signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable at specified timepoints. This endpoint was not applicable for participants of ‘’Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%’’

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)

Notes
[52] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	1	2
Units: Nanograms per millilitre
geometric mean (geometric coefficient of variation)
Cycle 1 (n=1,2)	55.00 ( 77777 )	24.47 ( 99999 )
Cycle 1 (n=1,1)	5770 ( 77777 )	8490 ( 132 )

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT

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End point title

Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ^[53]

End point description

Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample.

End point type

Secondary

End point timeframe

Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)

Notes
[53] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Participants
ADA against sasanlimab	0	0	0
ADA against SEA-TGT	1	0	0

No statistical analyses for this end point

Secondary: Phase 2 of Sub-Study B: Objective Response Rate by PD-L1 Expression in Available Tumor Tissue

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End point title

Phase 2 of Sub-Study B: Objective Response Rate by PD-L1 Expression in Available Tumor Tissue ^[54]

End point description

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Full analysis set included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Notes
[54] - 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: The end point is reporting statistics for the arms specified

End point values	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)
Number of subjects analysed	3	2	7
Units: Percentage of participants
number (confidence interval 95%)
ADA against sasanlimab	33.3 (0.8 to 90.6)	0.0 (0.0 to 84.2)	14.3 (0.4 to 57.9)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

Adverse event reporting additional description

Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study drug.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

v27.1

Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)

Reporting group description

Reporting group title

Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Reporting group title

Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.

Reporting group title

Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)

Reporting group description

Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to [>=]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.

Reporting group title

Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)

Reporting group description

Reporting group title

Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)

Reporting group description

Serious adverse events	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 4 (50.00%)	1 / 3 (33.33%)	4 / 7 (57.14%)	1 / 3 (33.33%)	0 / 2 (0.00%)	7 / 9 (77.78%)	3 / 6 (50.00%)
number of deaths (all causes)	0	1	3	1	0	4	5
number of deaths resulting from adverse events	0	0	0	0	0	2	1
Vascular disorders
Hypotension
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Pyrexia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic shock
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Reproductive system and breast disorders
Vaginal haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory failure
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	1 / 1	0 / 0
Investigations
Blood creatinine increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Ejection fraction decreased
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	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	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Cardiac tamponade
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Supraventricular tachycardia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	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	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Enteritis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Hepatobiliary disorders
Hepatitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	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	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Haematuria
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
Infections and infestations
Septic shock
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Sepsis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	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	0 / 1
Pneumonia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	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	0 / 0
COVID-19
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Diverticulitis
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	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	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	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	0 / 0
Metabolism and nutrition disorders
Hyperglycaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Dehydration
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0

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

Non-serious adverse events	Phase 1b of SSA: Sasa(300mg)+Enco(300mg)+Bini (45mg)	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)	Ph2SSB:2/3LNSCLC/PDL1:TPS>=1%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC PDL1:TPS1-49%(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Ph2SSB:1L NSCLC/PDL1:TPS>=50%9(mg)Sasa225+Axit5+SEA-TGT(1/kg)	Phase 1b of SSA: Sasa(300mg)+Enco(450mg)+Bini (45mg)	Phase 1b of SSB: Sasa (225mg) + Axit (5 mg) + SEA-TGT(1mg/kg)
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 4 (100.00%)	3 / 3 (100.00%)	7 / 7 (100.00%)	3 / 3 (100.00%)	2 / 2 (100.00%)	9 / 9 (100.00%)	6 / 6 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 9 (11.11%)	3 / 6 (50.00%)
occurrences all number	1	0	1	4	1	4	4
Hypotension
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	1	0	0
Thrombosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Embolism
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Phlebitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Hot flush
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Catheter site hypersensitivity
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Fatigue
subjects affected / exposed	1 / 4 (25.00%)	2 / 3 (66.67%)	3 / 7 (42.86%)	2 / 3 (66.67%)	1 / 2 (50.00%)	4 / 9 (44.44%)	3 / 6 (50.00%)
occurrences all number	1	3	5	3	1	5	5
Malaise
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0
Pain
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	4 / 9 (44.44%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	5	0
Oedema peripheral
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	2	0	0	0	0	1	1
Chest pain
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	1	0
Chills
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Influenza like illness
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Nodule
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Reproductive system and breast disorders
Vulvovaginal dryness
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Dysmenorrhoea
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Pelvic pain
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	1	1	0	0	0	1	1
Haemoptysis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Dyspnoea
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	2 / 7 (28.57%)	2 / 3 (66.67%)	0 / 2 (0.00%)	3 / 9 (33.33%)	0 / 6 (0.00%)
occurrences all number	0	1	2	3	0	3	0
Dysphonia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	4 / 7 (57.14%)	2 / 3 (66.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	4	3	0	0	1
Productive cough
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	1	1
Oropharyngeal pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	2	0
Pleural effusion
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	3	0
Pneumonitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	3 / 9 (33.33%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	3	0
Rhinorrhoea
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	1	0	0	0	1
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 4 (25.00%)	2 / 3 (66.67%)	2 / 7 (28.57%)	1 / 3 (33.33%)	1 / 2 (50.00%)	4 / 9 (44.44%)	1 / 6 (16.67%)
occurrences all number	1	3	2	5	2	9	2
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	2 / 6 (33.33%)
occurrences all number	0	2	0	0	0	2	3
Blood bilirubin increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0
Blood bicarbonate decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	2 / 3 (66.67%)	1 / 2 (50.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	2	1	0	2	1	1	1
Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	1	0	1	1	0	2
Aspartate aminotransferase increased
subjects affected / exposed	1 / 4 (25.00%)	3 / 3 (100.00%)	2 / 7 (28.57%)	1 / 3 (33.33%)	1 / 2 (50.00%)	3 / 9 (33.33%)	1 / 6 (16.67%)
occurrences all number	1	5	2	4	3	7	2
Amylase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	2 / 6 (33.33%)
occurrences all number	0	0	1	1	0	2	2
Blood creatinine increased
subjects affected / exposed	1 / 4 (25.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	2 / 3 (66.67%)	0 / 2 (0.00%)	0 / 9 (0.00%)	2 / 6 (33.33%)
occurrences all number	1	1	3	5	0	0	3
Blood corticotrophin increased
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Blood creatine increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Blood albumin decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0
Troponin increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Platelet count decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	2	0	0	1
Neutrophil count decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	2 / 3 (66.67%)	1 / 2 (50.00%)	0 / 9 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	0	0	10	3	0	7
Lipase increased
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	0 / 2 (0.00%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	1	0	1	2	0	2	3
International normalised ratio increased
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	2	0	1	1	2	0
Haemoglobin decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	3	0	0	0
Electrocardiogram T wave inversion
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
C-reactive protein increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Blood thyroid stimulating hormone decreased
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
White blood cell count decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	4	0	0	1
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	3	0	0	0	0	2	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	4 / 9 (44.44%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	15	0
Glomerular filtration rate decreased
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
SARS-CoV-2 test positive
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 2 (100.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	1	0	2	0	2
Cardiac disorders
Sinus bradycardia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Atrial fibrillation
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	1 / 6 (16.67%)
occurrences all number	1	0	1	0	0	2	1
Headache
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 2 (50.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	1	1	0	1	1	0
Neuralgia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Dysgeusia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	1	0
Paraesthesia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Presyncope
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Restless legs syndrome
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 4 (0.00%)	2 / 3 (66.67%)	0 / 7 (0.00%)	2 / 3 (66.67%)	0 / 2 (0.00%)	3 / 9 (33.33%)	2 / 6 (33.33%)
occurrences all number	0	2	0	3	0	10	4
Leukocytosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	2	0
Neutropenia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	4	0
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	1	0	1	0	0	1	0
Ear discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Eye disorders
Dry eye
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Vitreous floaters
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Uveitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	2	0
Visual impairment
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Narrow anterior chamber angle
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	2	0
Ocular discomfort
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Retinal fovea disorder
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	3 / 9 (33.33%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	3	0
Macular oedema
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	2	0
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Abdominal pain
subjects affected / exposed	0 / 4 (0.00%)	2 / 3 (66.67%)	1 / 7 (14.29%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	2	1	2	0	2	0
Abdominal pain upper
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Diarrhoea
subjects affected / exposed	1 / 4 (25.00%)	1 / 3 (33.33%)	3 / 7 (42.86%)	2 / 3 (66.67%)	0 / 2 (0.00%)	3 / 9 (33.33%)	3 / 6 (50.00%)
occurrences all number	1	1	3	4	0	5	4
Constipation
subjects affected / exposed	2 / 4 (50.00%)	0 / 3 (0.00%)	2 / 7 (28.57%)	2 / 3 (66.67%)	0 / 2 (0.00%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	2	0	2	2	0	2	2
Anorectal discomfort
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Dry mouth
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Nausea
subjects affected / exposed	2 / 4 (50.00%)	0 / 3 (0.00%)	3 / 7 (42.86%)	2 / 3 (66.67%)	0 / 2 (0.00%)	3 / 9 (33.33%)	1 / 6 (16.67%)
occurrences all number	2	0	5	2	0	3	1
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Mouth ulceration
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Odynophagia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Oral pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Pancreatitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	1	0	0
Vomiting
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	0 / 2 (0.00%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	0	0	1	1	0	2	2
Visceral venous thrombosis
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Abdominal pain lower
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0	0	0	0	0
Tooth discolouration
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Hepatobiliary disorders
Hepatitis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis acneiform
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	2	1
Alopecia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	1	0	0	0
Dry skin
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	2 / 7 (28.57%)	2 / 3 (66.67%)	1 / 2 (50.00%)	1 / 9 (11.11%)	2 / 6 (33.33%)
occurrences all number	1	0	2	2	1	1	2
Erythema
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Granuloma annulare
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	4	0
Pain of skin
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Hyperhidrosis
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	1	0
Pruritus
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	2 / 6 (33.33%)
occurrences all number	2	0	0	0	0	0	2
Rash
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	3 / 9 (33.33%)	2 / 6 (33.33%)
occurrences all number	1	0	0	0	0	3	3
Psoriasis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Rash erythematous
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0
Rash maculo-papular
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	2 / 3 (66.67%)	1 / 2 (50.00%)	3 / 9 (33.33%)	4 / 6 (66.67%)
occurrences all number	1	0	1	2	4	6	4
Hyperkeratosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Purpura
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Skin exfoliation
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Skin lesion
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Nodular rash
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Skin tightness
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Renal and urinary disorders
Glycosuria
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Proteinuria
subjects affected / exposed	0 / 4 (0.00%)	2 / 3 (66.67%)	2 / 7 (28.57%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	3 / 6 (50.00%)
occurrences all number	0	6	2	0	0	0	9
Urinary incontinence
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Pollakiuria
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Ureterolithiasis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	2	0
Hyperthyroidism
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Flank pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Back pain
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1	0	0	0	1
Arthralgia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	0 / 2 (0.00%)	4 / 9 (44.44%)	1 / 6 (16.67%)
occurrences all number	3	0	1	1	0	13	1
Muscle spasms
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
Muscular weakness
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Pain in extremity
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 2 (50.00%)	3 / 9 (33.33%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	2	4	0
Myalgia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	5 / 9 (55.56%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	11	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	1	0	0	0	1
Bone pain
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Connective tissue disorder
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Joint swelling
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Infections and infestations
Candida infection
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Herpes zoster
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 2 (50.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	1	0	0
Pharyngitis streptococcal
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Rash pustular
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0
Urinary tract infection
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	1
COVID-19
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Lower respiratory tract infection
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	5	0
Acne pustular
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Metabolism and nutrition disorders
Diabetic ketoacidosis
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Dehydration
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	1	0
Decreased appetite
subjects affected / exposed	1 / 4 (25.00%)	1 / 3 (33.33%)	2 / 7 (28.57%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	1	2	2	1	0	0	1
Hypercalcaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	1	0
Hypocalcaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	5	0	0	0
Hypoglycaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	1	0	8	0	2	1
Hyponatraemia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	1	0	1	2	1	1	0
Hypoalbuminaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	2 / 3 (66.67%)	0 / 2 (0.00%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	0	1	0	5	0	3	6
Hyperphosphataemia
subjects affected / exposed	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	1	0	0	0
Hyperkalaemia
subjects affected / exposed	0 / 4 (0.00%)	2 / 3 (66.67%)	0 / 7 (0.00%)	1 / 3 (33.33%)	1 / 2 (50.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	3	0	1	1	6	0
Hyperglycaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	2 / 6 (33.33%)
occurrences all number	0	0	2	0	0	1	2
Hypomagnesaemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	5	0	0	0
Hypophosphataemia
subjects affected / exposed	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	1	0	3	0	2	2
Hypercholesterolaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Hypernatraemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Hyperuricaemia
subjects affected / exposed	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	2	0

More information

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Were there any global substantial amendments to the protocol? Yes

21 Oct 2021

For Sub-Study B, reduced frequency of troponin clinical laboratory testing from every visit to Screening/C1D1 and when clinically indicated, because routine monitoring of troponin is not indicated for axitinib or approved immune checkpoint inhibitors (Section 13.10.1). Injectables were removed from the list of combined hormonal birth control methods that are highly effective and user dependent per new Pfizer standard because there are no approved injectable agents in this category (Sections 12.10.2.4 and 13.10.2.4.)

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.

Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated, and no data was collected and there are no results for this in the record.

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Clinical trials

Clinical Trial Results: A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)

Primary: Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)

Primary: Phase 1b of Sub-Study B: Percentage of Participants With DLT

Primary: Phase 1b of Sub-Study B: Percentage of Participants With DLT

Primary: Phase 2 Sub-Study B: Objective Response Rate

Primary: Phase 2 Sub-Study B: Objective Response Rate

Secondary: Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Secondary: Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study A: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study A: Durable Objective Response Rate (ORR)

Secondary: Phase 1b of Sub-Study A: Durable Objective Response Rate (ORR)

Secondary: Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Objective Response Rate

Secondary: Phase 1b of Sub-Study A: Objective Response Rate

Secondary: Phase 1b of Sub-Study A: Ctrough of Encorafenib

Secondary: Phase 1b of Sub-Study A: Ctrough of Encorafenib

Secondary: Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

Secondary: Phase 1b of Sub-Study A: Ctrough of Binimetinib

Secondary: Phase 1b of Sub-Study A: Ctrough of Binimetinib

Secondary: Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab

Secondary: Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab

Secondary: Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

Secondary: Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Hematology Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study B: Number of Participants With Shift from Baseline in Chemistry Parameters Values Based on CTCAE V5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0

Secondary: Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0

Secondary: Phase 1b of Sub-Study B: Duration of Response (DR)

Secondary: Phase 1b of Sub-Study B: Duration of Response (DR)

Secondary: Phase 1b of Sub-Study B: Objective Response Rate

Secondary: Phase 1b of Sub-Study B: Objective Response Rate

Secondary: Phase 1b of Sub-Study B: Progression-Free Survival (PFS)

Secondary: Phase 1b of Sub-Study B: Progression-Free Survival (PFS)

Secondary: Phase 2 of Sub-Study B: Time to Tumor Response (TTR)

Secondary: Phase 2 of Sub-Study B: Time to Tumor Response (TTR)

Secondary: Phase 2 of Sub-Study B: Duration of Response (DR)

Secondary: Phase 2 of Sub-Study B: Duration of Response (DR)

Secondary: Phase 1b of Sub-Study B: Time to Tumor Response (TTR)

Secondary: Phase 1b of Sub-Study B: Time to Tumor Response (TTR)

Secondary: Phase 2 of Sub-Study B: Overall Survival (OS)

Secondary: Phase 2 of Sub-Study B: Overall Survival (OS)

Secondary: Phase 2 of Sub-Study B: Progression-Free Survival (PFS)

Secondary: Phase 2 of Sub-Study B: Progression-Free Survival (PFS)

Secondary: Phase 1b of Sub-Study B: Cmax of Sasanlimab

Secondary: Phase 1b of Sub-Study B: Cmax of Sasanlimab

Secondary: Phase 1b of Sub-Study B: Cmax of SEA-TGT

Secondary: Phase 1b of Sub-Study B: Cmax of SEA-TGT

Secondary: Phase 1b of Sub-Study B: Cmax of Axitinib

Secondary: Phase 1b of Sub-Study B: Cmax of Axitinib

Secondary: Phase 2 of Sub-Study B: Cmax of sasanlimab

Secondary: Phase 2 of Sub-Study B: Cmax of sasanlimab

Secondary: Phase 2 of Sub-Study B: Cmax of axitinib

Secondary: Phase 2 of Sub-Study B: Cmax of axitinib

Secondary: Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

Secondary: Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab

Clinical Trial Results:
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)