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NCT03038100 · OUTCOME

PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17

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 until disease progression or death from any cause (up to approximately 55 months)

What was measured

Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.

Analysis population: PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.

Groups in this outcome

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

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

Analysis denominator · Participants

GroupSource count
Placebo With Paclitaxel, Carboplatin and Bevacizumab393
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab391

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo With Paclitaxel, Carboplatin and Bevacizumab18.50Not reported16.6221.36Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab20.83Not reported19.0624.21Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0376
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0376
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.62
        upper Limit
        21.36
        value
        18.50
      2. group Id
        OG001
        lower Limit
        19.06
        upper Limit
        24.21
        value
        20.83
denoms
  1. counts
    1. group Id
      OG000
      value
      393
    2. group Id
      OG001
      value
      391
    units
    Participants
description
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    id
    OG000
    title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
  2. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    id
    OG001
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
param Type
MEDIAN
population Description
PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.
reporting Status
POSTED
time Frame
From randomization until disease progression or death from any cause (up to approximately 55 months)
title
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice