NCT04269200 · OUTCOME

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

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 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

What was measured

To demonstrate 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 by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer

Analysis population: Full Analysis Set (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, patients 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, patients 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

China Cohort - SoC + Durvalumab

China 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.

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	9.6	Not reported	9.0	9.9	Not reported
Global Cohort - SoC + Durvalumab	10.2	Not reported	9.7	14.7	Not reported
Global Cohort - SoC + Durvalumab + Olaparib	15.1	Not reported	12.6	20.7	Not reported
China Cohort - SoC	9.7	Not reported	7.6	12.3	Not reported
China Cohort - SoC + Durvalumab	9.9	Not reported	8.2	20.6	Not reported
China Cohort - SoC + Durvalumab + Olaparib	9.9	Not reported	7.1	12.6	Not reported

Source statistical analyses

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

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.89
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.003
p Value Comment
Determined using a log-rank test stratified by mismatch repair (MMR) status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
param Type
Hazard Ratio (HR)
param Value
0.71
statistical Comment
Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.69
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Determined using a log-rank test stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
param Type
Hazard Ratio (HR)
param Value
0.55
statistical Comment
Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.25
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
0.73
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.61
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
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
0.96
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.89
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.003
p Value Comment
Determined using a log-rank test stratified by mismatch repair (MMR) status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
param Type
Hazard Ratio (HR)
param Value
0.71
statistical Comment
Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.69
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Determined using a log-rank test stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
param Type
Hazard Ratio (HR)
param Value
0.55
statistical Comment
Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.25
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
0.73
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.61
estimate Comment
A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
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
0.96
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
9.0
upper Limit
9.9
value
9.6
group Id
OG001
lower Limit
9.7
upper Limit
14.7
value
10.2
group Id
OG002
lower Limit
12.6
upper Limit
20.7
value
15.1
group Id
OG003
lower Limit
7.6
upper Limit
12.3
value
9.7
group Id
OG004
lower Limit
8.2
upper Limit
20.6
value
9.9
group Id
OG005
lower Limit
7.1
upper Limit
12.6
value
9.9

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, patients 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, patients 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

Full Analysis Set (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 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

title

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice