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NCT02775435 · OUTCOME

Overall Survival (OS)

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407) · Source last updated 2024-10-08

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 19 months

What was measured

OS was defined as the time from randomization to death due to any cause. OS is presented.

Analysis population: The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.

Groups in this outcome

Pembrolizumab + Chemotherapy Combo

Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).

Placebo + Chemotherapy

Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).

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 + Chemotherapy Combo278
Placebo + Chemotherapy281

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + Chemotherapy Combo15.9Not reported13.2NANA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Placebo + Chemotherapy11.3Not reported9.514.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0008
    p Value Comment
    Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0008
    p Value Comment
    Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. comment
        NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG000
        lower Limit
        13.2
        upper Limit
        NA
        value
        15.9
      2. group Id
        OG001
        lower Limit
        9.5
        upper Limit
        14.8
        value
        11.3
denoms
  1. counts
    1. group Id
      OG000
      value
      278
    2. group Id
      OG001
      value
      281
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. OS is presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).
    id
    OG000
    title
    Pembrolizumab + Chemotherapy Combo
  2. description
    Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
    id
    OG001
    title
    Placebo + Chemotherapy
param Type
MEDIAN
population Description
The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.
reporting Status
POSTED
time Frame
Up to approximately 19 months
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice