NCT04269200 · OUTCOME

Objective Response Rate (ORR) Based on Investigator Assessment

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: At baseline, every 9 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 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 ORR

Analysis population: All participants with measurable disease at baseline were included in the analysis. 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. Odds ratio only calculated for Global cohort (per statistical analysis plan \[SAP\]).

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	198
Global Cohort - SoC + Durvalumab	202
Global Cohort - SoC + Durvalumab + Olaparib	184
China Cohort - SoC	37
China Cohort - SoC + Durvalumab	32
China Cohort - SoC + Durvalumab + Olaparib	33

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Global Cohort - SoC	55.1	Not reported	Not reported	Not reported	Not reported
Global Cohort - SoC + Durvalumab	61.9	Not reported	Not reported	Not reported	Not reported
Global Cohort - SoC + Durvalumab + Olaparib	63.6	Not reported	Not reported	Not reported	Not reported
China Cohort - SoC	59.5	Not reported	Not reported	Not reported	Not reported
China Cohort - SoC + Durvalumab	59.4	Not reported	Not reported	Not reported	Not reported
China Cohort - SoC + Durvalumab + Olaparib	45.5	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.98
estimate Comment
An odds ratio greater than 1 favours SoC + durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Odds Ratio (OR)
param Value
1.32
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Logistic
ci Lower Limit
0.95
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.18
estimate Comment
An odds ratio greater than 1 favours SoC + durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Odds Ratio (OR)
param Value
1.44
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.98
estimate Comment
An odds ratio greater than 1 favours SoC + durvalumab.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Odds Ratio (OR)
param Value
1.32
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Logistic
ci Lower Limit
0.95
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.18
estimate Comment
An odds ratio greater than 1 favours SoC + durvalumab + Olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Odds Ratio (OR)
param Value
1.44
statistical Comment
Model was stratified by disease status (recurrent versus newly diagnosed).
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
55.1
group Id
OG001
value
61.9
group Id
OG002
value
63.6
group Id
OG003
value
59.5
group Id
OG004
value
59.4
group Id
OG005
value
45.5

denoms

counts
group Id
OG000
value
198
group Id
OG001
value
202
group Id
OG002
value
184
group Id
OG003
value
37
group Id
OG004
value
32
group Id
OG005
value
33
units
Participants

description

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

NUMBER

population Description

All participants with measurable disease at baseline were included in the analysis. 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. Odds ratio only calculated for Global cohort (per statistical analysis plan \[SAP\]).

reporting Status

POSTED

time Frame

At baseline, every 9 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

Objective Response Rate (ORR) Based on Investigator Assessment

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice