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2

Indication details

Control Arm
Placebo
Therapeutic Indication
Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Phase II)
Tumour Type
Gynaecological Malignancies
Tumour Sub-type
High-grade epithelial ovarian, fallopian tube or primary peritoneal cancer
Tumour Stage
Metastatic
Tumour Sub-Group
BRCA mutation
Trial Name
Study 19
NCT Number
NCT00753545
Trial Phase
Phase II

Approval details

FDA Approval
FDA approval August 2017
EMA Approval
EMA (CHMP) April 2019 EC decision June 2019

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
4.3 months
PFS Gain
6.9 months
PFS HR
0.18 (0.10-0.31)
OS Control
30.2 months
OS Gain
4.7 months
OS HR
0.62 (0.42-0.93), nominal P = 0.0214 (did not reach threshold for significance) (mature)

Adjustments

QoL Comment
Not improved

Final Score (after adjustments)

Preliminary non-curative score

3

Only improved PFS mature data shows no OS advantage and no improved QoL
1-
Final non-curative score

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
47
Scorecard version
1
Issue date
11.12.2018
Last update
19.07.2023
Olaparib Study 19

PRELIMINARY SCORE

PFS

ADJUSTMENTS

No improvement in QoL
Mature data shows no OS advantage and no improved QoL
Olaparib Study 19

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
2
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Gynaecological Malignancies
Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Phase II)
Olaparib
Placebo

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    Legend

    Information about symbols, abbrevations and color codes

    Red = negative
    Green = positive
    Grey = neutral
    ? Grey + ? = neutral with pending data
    DFS
    Disease-Free Survival
    DoR
    Duration of Response
    EFS
    Event-Free Survival
    HR
    Hazard Ratio
    NEB
    No evaluable benefit
    NI
    Non-inferiority Study
    ORR
    Overall Response Rate
    OS
    Overall Surival
    pCR
    Pathological Complete Response/Remission
    PFS
    Progression-Free Survival
    QoL
    Quality of Life
    RFS
    Relapse-Free Survival
    RR
    Response Rate

    QoL adjustments

    Other adjustments*

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    QoL adjustments

    Red = negative / deterioration

    Green = positive / improvement

    Other adjustments*

    Red = negative / deterioration

    Green = positive / improvement

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    * Other adjustments include:

    - Long-term plateau in the survival curve
    - Long-term plateau in the PFS curve
    - Early stopping or crossover
    - Only improved PFS mature data shows no OS advantage and no improved Qol.

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