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2

Indication details

Combined Agent(s)
Abiraterone + prednisone or prednisolone
Control Arm
Placebo + abiraterone + prednisone or prednisolone
FDA Therapeutic Indication
EMA: Olaparib is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. FDA: olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Prostate cancer
Tumour Stage
Metastatic
Trial Name
PROpel
NCT Number
NCT03732820
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval May 2023
EMA Approval
EMA (CHMP) November 2022 EC decision February 2023
Comment
EMA approval indication is for the ITT cohort, whereas FDA approved the drug combination only for the BRCA-mutated population.

Primary Outcome(s)

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

Outcome Data

PFS Control
16.6 months
PFS Gain
8.2 months
PFS HR
0.66 (0.54-0.81)
OS Control
34.7 months
OS Gain
7.4 months
OS HR
0.81 (0·67–1·00) Not significant

Adjustments

QoL Comment
No QoL benefit

Score (after adjustments)

Preliminary non-curative score

3

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

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
365
Scorecard version
1
Issue date
05.12.2022
Last update
16.01.2024
Olaparib PROpel

PRELIMINARY SCORE

PFS

ADJUSTMENTS

No QoL benefit
Only improved PFS mature data shows no OS advantage and no improved QoL
Olaparib PROpel

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
Genitourinary Cancers
EMA: Olaparib is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. FDA: olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
Olaparib + Abiraterone + prednisone or prednisolone
Placebo + abiraterone + prednisone or prednisolone

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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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