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NCT03924895 · OUTCOME

Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) · Source last updated 2026-06-30

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
Up to approximately 53 months

What was measured

EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.

Analysis population: Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.

Groups in this outcome

Arm A: Pembrolizumab + Surgery

Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.

Arm B: Surgery Alone

Participants receive standard of care surgery alone.

Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery

Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.

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

Analysis denominator · Participants

GroupSource count
Arm A: Pembrolizumab + Surgery0
Arm B: Surgery Alone174
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery170

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B: Surgery Alone15.7Not reported10.320.5Not reported
Arm C: Enfortumab Vedotin + Pembrolizumab + SurgeryNANot reported37.3NANA=median and upper limit not reached due to insufficient number of participants with an event

Source statistical analyses

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

  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.57
    group Description
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by cisplatin status (cisplatin-ineligible vs cisplatin-eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    One-sided p-value based on log-rank test stratified by cisplatin status (cisplatin-ineligible vs cisplatin eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
    param Type
    Hazard Ratio (HR)
    param Value
    0.40
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.57
    group Description
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by cisplatin status (cisplatin-ineligible vs cisplatin-eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    One-sided p-value based on log-rank test stratified by cisplatin status (cisplatin-ineligible vs cisplatin eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
    param Type
    Hazard Ratio (HR)
    param Value
    0.40
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        10.3
        upper Limit
        20.5
        value
        15.7
      2. comment
        NA=median and upper limit not reached due to insufficient number of participants with an event
        group Id
        OG002
        lower Limit
        37.3
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      174
    3. group Id
      OG002
      value
      170
    units
    Participants
description
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
    id
    OG000
    title
    Arm A: Pembrolizumab + Surgery
  2. description
    Participants receive standard of care surgery alone.
    id
    OG001
    title
    Arm B: Surgery Alone
  3. description
    Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
    id
    OG002
    title
    Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
param Type
MEDIAN
population Description
Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.
reporting Status
POSTED
time Frame
Up to approximately 53 months
title
Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice