NCT04269200 · OUTCOME

Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer · Source last updated 2026-08-07

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: At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months

What was measured

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2

Analysis population: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

Groups in this outcome

Global Cohort - SoC

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

Global Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

Global Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

China Cohort - SoC

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

China Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

China Cohort - SoC + Durvalumab + Olaparib

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
Global Cohort - SoC	241
Global Cohort - SoC + Durvalumab	238
Global Cohort - SoC + Durvalumab + Olaparib	239
China Cohort - SoC	44
China Cohort - SoC + Durvalumab	43
China Cohort - SoC + Durvalumab + Olaparib	42

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Global Cohort - SoC	19.1	Not reported	16.4	22.9	Not reported
Global Cohort - SoC + Durvalumab	22.2	Not reported	18.7	NA	Insufficient PFS2 events to estimate upper confidence limit.
Global Cohort - SoC + Durvalumab + Olaparib	NA	Not reported	NA	NA	Insufficient PFS2 events to estimate median and confidence limits.
China Cohort - SoC	24.2	Not reported	15.5	NA	Insufficient PFS2 events to estimate upper confidence limit.
China Cohort - SoC + Durvalumab	19.7	Not reported	15.3	NA	Insufficient PFS2 events to estimate upper confidence limit.
China Cohort - SoC + Durvalumab + Olaparib	15.3	Not reported	12.7	NA	Insufficient PFS2 events to estimate upper confidence limit.

Source statistical analyses

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

ci Lower Limit
0.59
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.07
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.80
statistical Comment
Model is unstratified.
statistical Method
Regression, Cox
ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.55
statistical Comment
Model is unstratified.
statistical Method
Regression, Cox
ci Lower Limit
0.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.21
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG003
OG004
non Inferiority Type
SUPERIORITY
p Value Comment
China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
1.03
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.90
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG003
OG005
non Inferiority Type
SUPERIORITY
p Value Comment
China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
1.38
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.59
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.07
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.80
statistical Comment
Model is unstratified.
statistical Method
Regression, Cox
ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.55
statistical Comment
Model is unstratified.
statistical Method
Regression, Cox
ci Lower Limit
0.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.21
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG003
OG004
non Inferiority Type
SUPERIORITY
p Value Comment
China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
1.03
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.90
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG003
OG005
non Inferiority Type
SUPERIORITY
p Value Comment
China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
1.38
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
16.4
upper Limit
22.9
value
19.1
comment
Insufficient PFS2 events to estimate upper confidence limit.
group Id
OG001
lower Limit
18.7
upper Limit
NA
value
22.2
comment
Insufficient PFS2 events to estimate median and confidence limits.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Insufficient PFS2 events to estimate upper confidence limit.
group Id
OG003
lower Limit
15.5
upper Limit
NA
value
24.2
comment
Insufficient PFS2 events to estimate upper confidence limit.
group Id
OG004
lower Limit
15.3
upper Limit
NA
value
19.7
comment
Insufficient PFS2 events to estimate upper confidence limit.
group Id
OG005
lower Limit
12.7
upper Limit
NA
value
15.3

denoms

counts
group Id
OG000
value
241
group Id
OG001
value
238
group Id
OG002
value
239
group Id
OG003
value
44
group Id
OG004
value
43
group Id
OG005
value
42
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
id
OG000
title
Global Cohort - SoC
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
id
OG001
title
Global Cohort - SoC + Durvalumab
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
id
OG002
title
Global Cohort - SoC + Durvalumab + Olaparib
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
id
OG003
title
China Cohort - SoC
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
id
OG004
title
China Cohort - SoC + Durvalumab
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
id
OG005
title
China Cohort - SoC + Durvalumab + Olaparib

param Type

MEDIAN

population Description

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

reporting Status

POSTED

time Frame

At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months

title

Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice

type

SECONDARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice