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NCT03221426 · OUTCOME

Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) · Source last updated 2026-03-09

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 75 months

What was measured

OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.

Analysis population: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the protocol.

Groups in this outcome

Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined

Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined

Placebo + XP/FP and Placebo + FLOT Cohort Combined

Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined502
Placebo + XP/FP and Placebo + FLOT Cohort Combined505

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort CombinedNANot reported59.2NANA = Median and upper limit were not reached at the data cut-off due to insufficient number of participants with an event
Placebo + XP/FP and Placebo + FLOT Cohort Combined55.7Not reported42.8NANA = Upper limit was not reached at the data cut-off 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
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04493
    p Value Comment
    One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04493
    p Value Comment
    One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = Median and upper limit were not reached at the data cut-off due to insufficient number of participants with an event
        group Id
        OG000
        lower Limit
        59.2
        upper Limit
        NA
        value
        NA
      2. comment
        NA = Upper limit was not reached at the data cut-off due to insufficient number of participants with an event
        group Id
        OG001
        lower Limit
        42.8
        upper Limit
        NA
        value
        55.7
denoms
  1. counts
    1. group Id
      OG000
      value
      502
    2. group Id
      OG001
      value
      505
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
dispersion Type
95% Confidence Interval
groups
  1. description
    Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
    id
    OG000
    title
    Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
  2. description
    Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
    id
    OG001
    title
    Placebo + XP/FP and Placebo + FLOT Cohort Combined
param Type
MEDIAN
population Description
The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the protocol.
reporting Status
POSTED
time Frame
Up to approximately 75 months
title
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice