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NCT03924895 · OUTCOME

Pathologic Downstaging {pDS) Rate Between Arm C and Arm B

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 53 months

What was measured

Pathologic downstaging (pDS) is defined as participants with a tumor classification of \<pT2. The pathologic stage \<pT2 includes pT0 (No residual primary tumor found in the tissue examined), pTis (carcinoma in situ; a flat, non-invasive cancer confined to the epithelial lining), pTa (Non-invasive papillary carcinoma limited to the urothelium) pT1 (tumor has invaded the connective tissue beneath the urothelium, but not the muscle layer) and N0 (No cancer found in the examined lymph nodes) in examined tissue from RC and PLND. The \<pT2 category represents a better outcome than participants with residual muscle-invasive disease (pT2 or higher) and/or any nodal involvement (N1/N2). The percentage of participants with pDS is presented.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B: Surgery Alone12.6Not reported8.118.5Not reported
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery65.9Not reported58.273.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    44.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    61.2
    estimate Comment
    Arm C: EV+ Pembrolizumab +Surgery vs Arm B: Surgery Alone
    group Description
    Based on Miettinen \& Nurminen method 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)
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    <0.000001
    p Value Comment
    p-value is nominal
    param Type
    Difference in percentage
    param Value
    53.1
    statistical Method
    Miettinen & Nurminen Method
Complete source fields
analyses
  1. ci Lower Limit
    44.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    61.2
    estimate Comment
    Arm C: EV+ Pembrolizumab +Surgery vs Arm B: Surgery Alone
    group Description
    Based on Miettinen \& Nurminen method 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)
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    <0.000001
    p Value Comment
    p-value is nominal
    param Type
    Difference in percentage
    param Value
    53.1
    statistical Method
    Miettinen & Nurminen Method
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        8.1
        upper Limit
        18.5
        value
        12.6
      2. group Id
        OG002
        lower Limit
        58.2
        upper Limit
        73.0
        value
        65.9
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      174
    3. group Id
      OG002
      value
      170
    units
    Participants
description
Pathologic downstaging (pDS) is defined as participants with a tumor classification of \<pT2. The pathologic stage \<pT2 includes pT0 (No residual primary tumor found in the tissue examined), pTis (carcinoma in situ; a flat, non-invasive cancer confined to the epithelial lining), pTa (Non-invasive papillary carcinoma limited to the urothelium) pT1 (tumor has invaded the connective tissue beneath the urothelium, but not the muscle layer) and N0 (No cancer found in the examined lymph nodes) in examined tissue from RC and PLND. The \<pT2 category represents a better outcome than participants with residual muscle-invasive disease (pT2 or higher) and/or any nodal involvement (N1/N2). The percentage of participants with pDS is presented.
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
NUMBER
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
Pathologic Downstaging {pDS) Rate Between Arm C and Arm B
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice