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NCT02409342 · OUTCOME

Investigator-Assessed PFS in Participants With PD-L1 Expression 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

Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)

Analysis population: Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the 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)210
Atezolizumab212

Reported measurements

SP263 >=50%-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)143
Atezolizumab150
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.9Not reported4.05.6Not reported
Atezolizumab7.0Not reported5.68.7Not reported
SP263 >=25%-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)168
Atezolizumab168
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.9Not reported4.25.6Not reported
Atezolizumab6.9Not reported5.68.4Not reported
SP263 >=1%-WT Population

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)210
Atezolizumab212
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)5.4Not reported4.45.7Not reported
Atezolizumab6.8Not reported5.58.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.511
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.890
    group Description
    SP263 \>=50%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.674
  2. ci Lower Limit
    0.539
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.904
    group Description
    SP263 \>=25%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.698
  3. ci Lower Limit
    0.577
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.910
    group Description
    SP263 \>=1%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.725
Complete source fields
analyses
  1. ci Lower Limit
    0.511
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.890
    group Description
    SP263 \>=50%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.674
  2. ci Lower Limit
    0.539
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.904
    group Description
    SP263 \>=25%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.698
  3. ci Lower Limit
    0.577
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.910
    group Description
    SP263 \>=1%-WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified analysis
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.725
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.0
        upper Limit
        5.6
        value
        4.9
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        8.7
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        150
      units
      Participants
    title
    SP263 >=50%-WT Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        5.6
        value
        4.9
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        8.4
        value
        6.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        168
      2. group Id
        OG001
        value
        168
      units
      Participants
    title
    SP263 >=25%-WT Population
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.4
        upper Limit
        5.7
        value
        5.4
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        8.0
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        210
      2. group Id
        OG001
        value
        212
      units
      Participants
    title
    SP263 >=1%-WT Population
denoms
  1. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      212
    units
    Participants
description
Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)
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 PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the 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 PD-L1 Expression According to RECIST v1.1
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice