NCT03038100 · OUTCOME

Overall Survival - 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 up to death from any cause (up to approximately 59 months)

What was measured

Overall Survival (OS) is defined as the time from randomization to death from any cause.

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

Group	Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab	393
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	391

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab	49.15	Not reported	45.54	NA	The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	NA	Not reported	NA	NA	67.3% of the participants were censored and the median was not reached.

Source statistical analyses

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

ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Description
Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1316
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Description
Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1316
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Log Rank

classes

categories
measurements
comment
The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
group Id
OG000
lower Limit
45.54
upper Limit
NA
value
49.15
comment
67.3% of the participants were censored and the median was not reached.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
393
group Id
OG001
value
391
units
Participants

description

Overall Survival (OS) is defined as the time from randomization to death from any cause.

dispersion Type

95% Confidence Interval

groups

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
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 up to death from any cause (up to approximately 59 months)

title

Overall Survival - PD-L1-Positive Subpopulation

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice