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NCT03777657 · OUTCOME

Overall Response Rate (ORR) in the ITT Analysis Set

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; 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

ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.

Analysis population: Intent-to-Treat (ITT) 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 + Chemotherapy501
Placebo + Chemotherapy496

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tislelizumab + Chemotherapy47.3Not reported42.951.8Not reported
Placebo + Chemotherapy40.5Not reported36.245.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.72
    estimate Comment
    Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.33
Complete source fields
analyses
  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.72
    estimate Comment
    Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.33
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.9
        upper Limit
        51.8
        value
        47.3
      2. group Id
        OG001
        lower Limit
        36.2
        upper Limit
        45.0
        value
        40.5
denoms
  1. counts
    1. group Id
      OG000
      value
      501
    2. group Id
      OG001
      value
      496
    units
    Participants
description
ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.
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
NUMBER
population Description
Intent-to-Treat (ITT) Analysis Set
reporting Status
POSTED
time Frame
Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; 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
Overall Response Rate (ORR) in the ITT Analysis Set
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice