NCT02564263 · OUTCOME

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) · Source last updated 2023-03-13

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: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

What was measured

OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.

Analysis population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).

Chemotherapy

Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).

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

Analysis denominator · Participants

Group	Source count
Pembrolizumab	107
Chemotherapy	115

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab	9.3	Not reported	6.6	12.5	Not reported
Chemotherapy	6.7	Not reported	5.1	8.2	Not reported

Source statistical analyses

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

ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.00855
p Value Comment
One-sided p-value based on stratified log-rank test
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.00855
p Value Comment
One-sided p-value based on stratified log-rank test
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
6.6
upper Limit
12.5
value
9.3
group Id
OG001
lower Limit
5.1
upper Limit
8.2
value
6.7

denoms

counts
group Id
OG000
value
107
group Id
OG001
value
115
units
Participants

description

OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.

dispersion Type

95% Confidence Interval

groups

description
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
id
OG000
title
Pembrolizumab
description
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
id
OG001
title
Chemotherapy

param Type

MEDIAN

population Description

The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

reporting Status

POSTED

time Frame

Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

title

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)

type

PRIMARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice