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NCT02409342 · OUTCOME

Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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 to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

What was measured

PFS according to RECIST v1.1 in the bTMB subpopulations.

Analysis population: Analysis was performed for participants with bTMB \>=10 Intent-to-treat Wild Type Population.

Groups in this outcome

Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Atezolizumab

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

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

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)83
Atezolizumab92

Reported measurements

bTMB >=10-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)83
Atezolizumab92
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.3Not reported3.15.4Not reported
Atezolizumab5.5Not reported2.86.8Not reported
bTMB >=16-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)45
Atezolizumab42
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.4Not reported2.85.7Not reported
Atezolizumab6.8Not reported4.311.6Not reported
bTMB >=20-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)29
Atezolizumab27
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)5.2Not reported3.26.4Not reported
Atezolizumab6.8Not reported4.317.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.525
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.052
    group Description
    bTMB \>=10-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.743
  2. ci Lower Limit
    0.331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.924
    group Description
    bTMB \>=16-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.553
  3. ci Lower Limit
    0.295
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.062
    group Description
    bTMB \>=20-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.560
Complete source fields
analyses
  1. ci Lower Limit
    0.525
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.052
    group Description
    bTMB \>=10-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.743
  2. ci Lower Limit
    0.331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.924
    group Description
    bTMB \>=16-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.553
  3. ci Lower Limit
    0.295
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.062
    group Description
    bTMB \>=20-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.560
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        5.4
        value
        4.3
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        6.8
        value
        5.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        92
      units
      Participants
    title
    bTMB >=10-WT Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        5.7
        value
        4.4
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        11.6
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        42
      units
      Participants
    title
    bTMB >=16-WT Population
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.2
        upper Limit
        6.4
        value
        5.2
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        17.2
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    bTMB >=20-WT Population
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      92
    units
    Participants
description
PFS according to RECIST v1.1 in the bTMB subpopulations.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG000
    title
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
  2. description
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG001
    title
    Atezolizumab
param Type
MEDIAN
population Description
Analysis was performed for participants with bTMB \>=10 Intent-to-treat Wild Type Population.
reporting Status
POSTED
time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
title
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice