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NCT04223856 · OUTCOME

Overall Survival (OS)

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer · Source last updated 2026-05-29

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
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)

What was measured

OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.

Analysis population: ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.

Groups in this outcome

Enfortumab Vedotin + Pembrolizumab

Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.

Standard of Care

Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.

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

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin + Pembrolizumab442
Standard of Care444

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin + Pembrolizumab31.5Not reported25.4NAUpper limit of 95% CI could not be estimated due to insufficient number of participants with event.
Standard of Care16.1Not reported13.918.3Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.376
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.582
    estimate Comment
    HR was calculated using stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    param Type
    Hazard Ratio (HR)
    param Value
    0.468
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.376
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.582
    estimate Comment
    HR was calculated using stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    param Type
    Hazard Ratio (HR)
    param Value
    0.468
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI could not be estimated due to insufficient number of participants with event.
        group Id
        OG000
        lower Limit
        25.4
        upper Limit
        NA
        value
        31.5
      2. group Id
        OG001
        lower Limit
        13.9
        upper Limit
        18.3
        value
        16.1
denoms
  1. counts
    1. group Id
      OG000
      value
      442
    2. group Id
      OG001
      value
      444
    units
    Participants
description
OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
    id
    OG000
    title
    Enfortumab Vedotin + Pembrolizumab
  2. description
    Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
    id
    OG001
    title
    Standard of Care
param Type
MEDIAN
population Description
ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
reporting Status
POSTED
time Frame
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice