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NCT02988817 · OUTCOME

Overall Survival (OS)

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 through 44.5 months (maximum observed duration)

What was measured

Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.

Analysis population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.

Groups in this outcome

Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.st.

Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W11
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W22
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W16
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W44
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W55
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W21
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W26

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3WNANot reportedNANAMedian and 95% confidence interval were not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W4.3Not reportedNANA95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W6.4Not reported6.3NAUpper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3WNANot reported6.7NAMedian and upper limit of 95% confidence interval were not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W14.5Not reported3.1NAUpper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W7.6Not reported2.212.1Not reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W44.5Not reportedNANA95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W6.7Not reported6.7NAUpper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W14.3Not reportedNANA95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W7.7Not reported4.3NAUpper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W21.7Not reported0.4NAUpper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W16.5Not reported4.125.9Not reported
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W8.6Not reported3.619.1Not reported
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W9.2Not reported4.014.9Not reported
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W17.1Not reported5.724.3Not reported
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W7.0Not reported5.211.6Not reported
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W8.4Not reported6.512.4Not reported
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W11.3Not reported8.015.5Not reported
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W8.7Not reported5.814.1Not reported
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W8.0Not reported4.112.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% confidence interval were not reached due to an insufficient events being observed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        4.3
      3. comment
        Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG002
        lower Limit
        6.3
        upper Limit
        NA
        value
        6.4
      4. comment
        Median and upper limit of 95% confidence interval were not reached due to an insufficient events being observed.
        group Id
        OG003
        lower Limit
        6.7
        upper Limit
        NA
        value
        NA
      5. comment
        Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG004
        lower Limit
        3.1
        upper Limit
        NA
        value
        14.5
      6. group Id
        OG005
        lower Limit
        2.2
        upper Limit
        12.1
        value
        7.6
      7. comment
        95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        44.5
      8. comment
        Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG007
        lower Limit
        6.7
        upper Limit
        NA
        value
        6.7
      9. comment
        95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG008
        lower Limit
        NA
        upper Limit
        NA
        value
        14.3
      10. comment
        Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG009
        lower Limit
        4.3
        upper Limit
        NA
        value
        7.7
      11. comment
        Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
        group Id
        OG010
        lower Limit
        0.4
        upper Limit
        NA
        value
        21.7
      12. group Id
        OG011
        lower Limit
        4.1
        upper Limit
        25.9
        value
        16.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      22
    units
    Participants
description
Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
    id
    OG000
    title
    Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
  2. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
    id
    OG001
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
  3. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
    id
    OG002
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
  4. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
    id
    OG003
    title
    Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
  5. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
    id
    OG004
    title
    Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
  6. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG005
    title
    Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
  7. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
    id
    OG006
    title
    Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
  8. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
    id
    OG007
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
  9. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
    id
    OG008
    title
    Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
  10. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
    id
    OG009
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
  11. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
    id
    OG010
    title
    Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
  12. description
    Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG011
    title
    Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
param Type
MEDIAN
population Description
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
reporting Status
POSTED
time Frame
Day 1 through 44.5 months (maximum observed duration)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice