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    Clinical Trial Results:
    HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2020-000730-17
    Trial protocol
    		 FR   DE   NL   AT   BE   IT   BG  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2024
    First version publication date
    25 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U31402-A-U201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04619004
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mount Airy Rd., Basking Ridge, United States, 07920
    Public contact
    Daiichi Sankyo Contact for Clinical Trial Information, Daiichi Sankyo, Inc., +1 908-992-6400, CTRinfo@dsi.com
    Scientific contact
    Daiichi Sankyo Contact for Clinical Trial Information, Daiichi Sankyo, Inc., +1 908-992-6400, CTRinfo@dsi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    20 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to investigate HER3-DXd antitumor activity, as measured by ORR as assessed by BICR per RECIST v1.1, in subjects with locally advanced or metastatic EGFRm (exon 19 deletion or L858R mutation) NSCLC.
    Protection of trial subjects
    This study was conducted in compliance with the protocol, the ethical principles that have their origin in the Declaration of Helsinki, the ICH consolidated Guideline E6 for GCP (CPMP/ICH/135/95), and applicable regulatory requirements. The initial protocol, protocol amendments, the ICFs, and information sheets were approved by the appropriate and applicable Independent Ethics Committees or Institutional Review Boards.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 65
    Country: Number of subjects enrolled
    Japan: 59
    Country: Number of subjects enrolled
    Korea, Republic of: 28
    Country: Number of subjects enrolled
    Singapore: 6
    Country: Number of subjects enrolled
    Taiwan: 19
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Australia: 20
    Worldwide total number of subjects
    277
    EEA total number of subjects
    78
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    158
    From 65 to 84 years
    119
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 277 participants were enrolled and randomized to treatment at clinical sites in the United States, Japan, Republic of Korea, Singapore, Taiwan, Austria, Belgium, Bulgaria, France, Germany, Italy, Netherlands, Spain, United Kingdom, and Australia. Two participants did not receive any treatment (1 person in each treatment arm).

    Pre-assignment
    Screening details
    		 The Screening Period started on the day of signing the main ICF and had a maximum duration of 35 days. During the Screening Period, the participant’s eligibility was determined. The study allowed rescreening once for any participant who failed to meet eligibility criteria upon initial Screening or whose Screening window had elapsed.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patritumab deruxtecan 5.6 mg/kg
    Arm description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Patritumab Deruxtecan (Fixed dose)
    Investigational medicinal product code
    Other name
    U3-1402, HER3-DXd
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.

    Arm title
    		 Patritumab deruxtecan Up-Titration
    Arm description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen
    Arm type
    		 Experimental

    Investigational medicinal product name
    Patritumab Deruxtecan (Up-titration)
    Investigational medicinal product code
    Other name
    U3-1402, HER3-DXd
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle 1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered on Day 1 of each 21-day cycle.

    Number of subjects in period 1
    		Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Started
    226
    51
    Completed
    87
    14
    Not completed
    139
    37
         Adverse event, serious fatal
    114
    28
         Consent withdrawn by subject
    24
    7
         Other - Not specified
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patritumab deruxtecan 5.6 mg/kg
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)

    Reporting group title
    Patritumab deruxtecan Up-Titration
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen

    Reporting group values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration Total
    Number of subjects
    		 226 51 277
    Age categorical
    Units: Subjects
        <65 years
    		 122 36 158
        ≥65 years
    		 104 15 119
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ± 9.86 59.8 ± 10.07 -
    Gender categorical
    Units: Subjects
        Female
    		 133 29 162
        Male
    		 93 22 115
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 106 32 138
        Black or African-American
    		 3 1 4
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        White
    		 92 15 107
        Other
    		 24 3 27

    End points

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    End points reporting groups
    Reporting group title
    Patritumab deruxtecan 5.6 mg/kg
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)

    Reporting group title
    Patritumab deruxtecan Up-Titration
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen

    Primary: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

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    End point title
    		 Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) [1]
    End point description
    ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
    End point type
    Primary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    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 were reported for this endpoint; descriptive analyses were used to assess this outcome.
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    225
    50
    Units: participants
    64
    8
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    64
    8
    Units: months
    median (confidence interval 95%)
        Duration of response (BICR)
    6.0 (4.4 to 7.2)
    7.1 (2.8 to 15.2)
        Duration of response (Investigator)
    6.9 (5.6 to 7.2)
    5.1 (2.6 to 9.5)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    225
    50
    Units: months
    median (confidence interval 95%)
        Progression-free survival (BICR)
    5.5 (5.1 to 5.9)
    6.7 (4.2 to 8.8)
        Progression-free survival (Investigator)
    5.5 (4.2 to 5.7)
    5.3 (4.0 to 8.2)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) as Assessed by the Investigator

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    End point title
    		 Objective Response Rate (ORR) as Assessed by the Investigator
    End point description
    ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    225
    50
    Units: participants
    56
    8
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    225
    50
    Units: participants
        Disease control rate (BICR)
    166
    38
        Disease control rate (Investigator)
    169
    37
    No statistical analyses for this end point

    Secondary: Time to Tumor Response (TTR)

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    End point title
    		 Time to Tumor Response (TTR)
    End point description
    TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    64
    8
    Units: months
    arithmetic mean (standard deviation)
        Time to response (BICR)
    2.2 ± 1.31
    1.7 ± 0.61
        Time to response (Investigator)
    2.5 ± 1.78
    2.1 ± 1.09
    No statistical analyses for this end point

    Secondary: Best percentage change in the sum of diameters (SoD) of measurable tumors

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    End point title
    		 Best percentage change in the sum of diameters (SoD) of measurable tumors
    End point description
    The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.
    End point type
    Secondary
    End point timeframe
    Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
    End point values
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Number of subjects analysed
    210
    49
    Units: percentage change from baseline
    arithmetic mean (standard deviation)
        Sum of diameters (BICR)
    -25.66 ± 30.39
    -17.48 ± 29.54
        Sum of diameters (Investigator)
    -20.84 ± 27.01
    -11.46 ± 29.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date).
    Adverse event reporting additional description
    Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Patritumab deruxtecan 5.6 mg/kg
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)

    Reporting group title
    Patritumab deruxtecan Up-Titration
    Reporting group description
    		 Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen

    Serious adverse events
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Total subjects affected by serious adverse events
         subjects affected / exposed
    90 / 225 (40.00%)
    16 / 50 (32.00%)
         number of deaths (all causes)
    114
    28
         number of deaths resulting from adverse events
    24
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to meninges
         subjects affected / exposed
    3 / 225 (1.33%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metastasis to central nervous system
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    11 / 225 (4.89%)
    4 / 50 (8.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 11
    0 / 4
    Asthenia
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    9 / 225 (4.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    9 / 9
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Pleural effusion
         subjects affected / exposed
    4 / 225 (1.78%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    4 / 225 (1.78%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 225 (2.67%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    5 / 225 (2.22%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 225 (1.78%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 225 (2.22%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic duct obstruction
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hypertransaminaemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 225 (2.22%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    4 / 225 (1.78%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Patritumab deruxtecan 5.6 mg/kg Patritumab deruxtecan Up-Titration
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    223 / 225 (99.11%)
    49 / 50 (98.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 225 (2.22%)
    3 / 50 (6.00%)
         occurrences all number
    5
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    69 / 225 (30.67%)
    12 / 50 (24.00%)
         occurrences all number
    79
    14
    Malaise
         subjects affected / exposed
    15 / 225 (6.67%)
    6 / 50 (12.00%)
         occurrences all number
    23
    16
    Oedema peripheral
         subjects affected / exposed
    20 / 225 (8.89%)
    3 / 50 (6.00%)
         occurrences all number
    22
    3
    Pyrexia
         subjects affected / exposed
    22 / 225 (9.78%)
    6 / 50 (12.00%)
         occurrences all number
    30
    8
    Asthenia
         subjects affected / exposed
    41 / 225 (18.22%)
    7 / 50 (14.00%)
         occurrences all number
    70
    14
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    37 / 225 (16.44%)
    5 / 50 (10.00%)
         occurrences all number
    40
    7
    Dyspnoea
         subjects affected / exposed
    40 / 225 (17.78%)
    2 / 50 (4.00%)
         occurrences all number
    44
    2
    Epistaxis
         subjects affected / exposed
    22 / 225 (9.78%)
    1 / 50 (2.00%)
         occurrences all number
    27
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    17 / 225 (7.56%)
    5 / 50 (10.00%)
         occurrences all number
    17
    5
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    38 / 225 (16.89%)
    9 / 50 (18.00%)
         occurrences all number
    56
    13
    White blood cell count decreased
         subjects affected / exposed
    48 / 225 (21.33%)
    9 / 50 (18.00%)
         occurrences all number
    85
    20
    Neutrophil count decreased
         subjects affected / exposed
    61 / 225 (27.11%)
    15 / 50 (30.00%)
         occurrences all number
    104
    32
    Platelet count decreased
         subjects affected / exposed
    65 / 225 (28.89%)
    13 / 50 (26.00%)
         occurrences all number
    88
    22
    Alanine aminotransferase increased
         subjects affected / exposed
    26 / 225 (11.56%)
    9 / 50 (18.00%)
         occurrences all number
    39
    15
    Blood creatinine increased
         subjects affected / exposed
    12 / 225 (5.33%)
    3 / 50 (6.00%)
         occurrences all number
    18
    4
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    13 / 225 (5.78%)
    1 / 50 (2.00%)
         occurrences all number
    15
    1
    Lymphocyte count decreased
         subjects affected / exposed
    16 / 225 (7.11%)
    3 / 50 (6.00%)
         occurrences all number
    27
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    21 / 225 (9.33%)
    1 / 50 (2.00%)
         occurrences all number
    25
    1
    Weight decreased
         subjects affected / exposed
    23 / 225 (10.22%)
    9 / 50 (18.00%)
         occurrences all number
    24
    9
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    6 / 225 (2.67%)
    4 / 50 (8.00%)
         occurrences all number
    7
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 225 (11.56%)
    9 / 50 (18.00%)
         occurrences all number
    28
    13
    Dysgeusia
         subjects affected / exposed
    14 / 225 (6.22%)
    1 / 50 (2.00%)
         occurrences all number
    17
    1
    Dizziness
         subjects affected / exposed
    13 / 225 (5.78%)
    4 / 50 (8.00%)
         occurrences all number
    16
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    74 / 225 (32.89%)
    15 / 50 (30.00%)
         occurrences all number
    107
    23
    Thrombocytopenia
         subjects affected / exposed
    33 / 225 (14.67%)
    5 / 50 (10.00%)
         occurrences all number
    59
    5
    Neutropenia
         subjects affected / exposed
    23 / 225 (10.22%)
    5 / 50 (10.00%)
         occurrences all number
    35
    13
    Leukopenia
         subjects affected / exposed
    12 / 225 (5.33%)
    1 / 50 (2.00%)
         occurrences all number
    17
    3
    Eye disorders
    Vision blurred
         subjects affected / exposed
    6 / 225 (2.67%)
    4 / 50 (8.00%)
         occurrences all number
    6
    4
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    26 / 225 (11.56%)
    7 / 50 (14.00%)
         occurrences all number
    30
    7
    Abdominal pain
         subjects affected / exposed
    19 / 225 (8.44%)
    5 / 50 (10.00%)
         occurrences all number
    20
    6
    Vomiting
         subjects affected / exposed
    60 / 225 (26.67%)
    11 / 50 (22.00%)
         occurrences all number
    70
    15
    Diarrhoea
         subjects affected / exposed
    62 / 225 (27.56%)
    11 / 50 (22.00%)
         occurrences all number
    91
    21
    Nausea
         subjects affected / exposed
    147 / 225 (65.33%)
    32 / 50 (64.00%)
         occurrences all number
    215
    48
    Constipation
         subjects affected / exposed
    77 / 225 (34.22%)
    15 / 50 (30.00%)
         occurrences all number
    95
    19
    Abdominal pain upper
         subjects affected / exposed
    14 / 225 (6.22%)
    3 / 50 (6.00%)
         occurrences all number
    15
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 225 (3.11%)
    3 / 50 (6.00%)
         occurrences all number
    8
    3
    Dyspepsia
         subjects affected / exposed
    14 / 225 (6.22%)
    2 / 50 (4.00%)
         occurrences all number
    19
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    57 / 225 (25.33%)
    0 / 50 (0.00%)
         occurrences all number
    57
    0
    Pruritus
         subjects affected / exposed
    13 / 225 (5.78%)
    0 / 50 (0.00%)
         occurrences all number
    15
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    21 / 225 (9.33%)
    7 / 50 (14.00%)
         occurrences all number
    25
    7
    Arthralgia
         subjects affected / exposed
    20 / 225 (8.89%)
    4 / 50 (8.00%)
         occurrences all number
    22
    4
    Myalgia
         subjects affected / exposed
    7 / 225 (3.11%)
    3 / 50 (6.00%)
         occurrences all number
    7
    6
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    10 / 225 (4.44%)
    3 / 50 (6.00%)
         occurrences all number
    12
    3
    Pneumonia
         subjects affected / exposed
    11 / 225 (4.89%)
    3 / 50 (6.00%)
         occurrences all number
    12
    3
    COVID-19
         subjects affected / exposed
    20 / 225 (8.89%)
    3 / 50 (6.00%)
         occurrences all number
    23
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    92 / 225 (40.89%)
    21 / 50 (42.00%)
         occurrences all number
    115
    28
    Hypokalaemia
         subjects affected / exposed
    37 / 225 (16.44%)
    6 / 50 (12.00%)
         occurrences all number
    49
    8
    Hyperglycaemia
         subjects affected / exposed
    15 / 225 (6.67%)
    2 / 50 (4.00%)
         occurrences all number
    18
    3
    Hypoalbuminaemia
         subjects affected / exposed
    20 / 225 (8.89%)
    1 / 50 (2.00%)
         occurrences all number
    27
    1
    Hyponatraemia
         subjects affected / exposed
    15 / 225 (6.67%)
    2 / 50 (4.00%)
         occurrences all number
    18
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2020
    Revised number of planned sites, revised eligibility criteria, removed text regarding Independent Monitoring Committee, updated details on tumor assessments, defined new Screening period and procedures for rescreening, revised sample size, modified schedule of events for study assessments, and provided additional details on study/site closure,
    30 Mar 2021
    Inclusion criteria were updated, screening assessments were revised, benefits and risk section was modified, highly effective contraception was defined, and additional clarification was provided for the reporting and management of safety events.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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