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NCT03777657 · OUTCOME

Progression-free Survival (PFS) in PD-L1 Positive Participants

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma · Source last updated 2025-02-14

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 up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.

What was measured

Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Analysis population: PD-L1 Positive Analysis Set

Groups in this outcome

Tislelizumab + Chemotherapy

Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Placebo + Chemotherapy

Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Tislelizumab + Chemotherapy274
Placebo + Chemotherapy272

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy7.2Not reported5.88.4Not reported
Placebo + Chemotherapy5.9Not reported5.67.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
Complete source fields
analyses
  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.8
        upper Limit
        8.4
        value
        7.2
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        7.0
        value
        5.9
denoms
  1. counts
    1. group Id
      OG000
      value
      274
    2. group Id
      OG001
      value
      272
    units
    Participants
description
Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Tislelizumab + Chemotherapy
  2. description
    Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Placebo + Chemotherapy
param Type
MEDIAN
population Description
PD-L1 Positive Analysis Set
reporting Status
POSTED
time Frame
From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
title
Progression-free Survival (PFS) in PD-L1 Positive Participants
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice