NCT01844986 · OUTCOME

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. · Source last updated 2025-12-10

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: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

What was measured

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Analysis population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

Groups in this outcome

Olaparib 300mg Tablets (Global Cohort)

Taken orally twice daily

Placebo Tablets (Global Cohort)

Taken orally twice daily

Olaparib 300mg Tablets (China Cohort)

Taken orally twice daily

Placebo Tablets (China Cohort)

Taken orally twice daily

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
Olaparib 300mg Tablets (Global Cohort)	260
Placebo Tablets (Global Cohort)	131
Olaparib 300mg Tablets (China Cohort)	44
Placebo Tablets (China Cohort)	20

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Olaparib 300mg Tablets (Global Cohort)	51.8	Not reported	44.3	NA	Insufficient events to estimate upper confidence limit.
Placebo Tablets (Global Cohort)	15.1	Not reported	12.7	20.5	Not reported
Olaparib 300mg Tablets (China Cohort)	34.3	Not reported	23.1	NA	Insufficient events to estimate upper confidence limit.
Placebo Tablets (China Cohort)	10.3	Not reported	6.9	NA	Insufficient 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
0.22
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.40
estimate Comment
A hazard ratio \< 1 favours olaparib
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Determined using a log-rank test stratified by response to previous platinum chemotherapy
param Type
Hazard Ratio (HR)
param Value
0.30
statistical Comment
Model includes a factor for response to previous platinum chemotherapy
statistical Method
Regression, Cox
ci Lower Limit
0.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.23
estimate Comment
A hazard ratio \<1 favours Olaparib.
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value Comment
Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Comment
Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.22
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.40
estimate Comment
A hazard ratio \< 1 favours olaparib
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Determined using a log-rank test stratified by response to previous platinum chemotherapy
param Type
Hazard Ratio (HR)
param Value
0.30
statistical Comment
Model includes a factor for response to previous platinum chemotherapy
statistical Method
Regression, Cox
ci Lower Limit
0.29
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.23
estimate Comment
A hazard ratio \<1 favours Olaparib.
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value Comment
Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Comment
Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
statistical Method
Regression, Cox

classes

categories
measurements
comment
Insufficient events to estimate upper confidence limit.
group Id
OG000
lower Limit
44.3
upper Limit
NA
value
51.8
group Id
OG001
lower Limit
12.7
upper Limit
20.5
value
15.1
comment
Insufficient events to estimate upper confidence limit.
group Id
OG002
lower Limit
23.1
upper Limit
NA
value
34.3
comment
Insufficient events to estimate upper confidence limit.
group Id
OG003
lower Limit
6.9
upper Limit
NA
value
10.3

denoms

counts
group Id
OG000
value
260
group Id
OG001
value
131
group Id
OG002
value
44
group Id
OG003
value
20
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Taken orally twice daily
id
OG000
title
Olaparib 300mg Tablets (Global Cohort)
description
Taken orally twice daily
id
OG001
title
Placebo Tablets (Global Cohort)
description
Taken orally twice daily
id
OG002
title
Olaparib 300mg Tablets (China Cohort)
description
Taken orally twice daily
id
OG003
title
Placebo Tablets (China Cohort)

param Type

MEDIAN

population Description

Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

reporting Status

POSTED

time Frame

Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

title

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice