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NCT01953692 · OUTCOME

Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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
90% Confidence Interval
Time frame
Up to approximately 78.5 months

What was measured

ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The pooled Cohort 4 sub-cohorts were evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.

Analysis population: All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).

Groups in this outcome

Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)

Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

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

Analysis denominator · Participants

GroupSource count
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)86

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)22.1Not reported15.030.7Not reported

Source statistical analyses

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

  1. group Description
    Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7696
    p Value Comment
    one-sided p-value
    statistical Method
    exact binomial distribution
Complete source fields
analyses
  1. group Description
    Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7696
    p Value Comment
    one-sided p-value
    statistical Method
    exact binomial distribution
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.0
        upper Limit
        30.7
        value
        22.1
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The pooled Cohort 4 sub-cohorts were evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG000
    title
    Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
param Type
NUMBER
population Description
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
reporting Status
POSTED
time Frame
Up to approximately 78.5 months
title
Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
type
PRIMARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice