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3

Indication details

Control Arm
Placebo
Therapeutic Indication
Maintenance treatment for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based ChT
Tumour Type
Gynaecological Malignancies
Tumour Sub-type
Ovarian, fallopian tubes and peritoneum cancer
Tumour Stage
Advanced
Trial Name
PRIMA/ENGOT-OV26/COG-3012
NCT Number
NCT02655016
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval April 2020
EMA Approval
EMA (CHMP) September 2020 EC decision November 2020

Primary Outcome(s)

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

Outcome Data

PFS Control
8.2 months
PFS Gain
5.6 months
PFS HR
0.62 (0.50-0.76)
OS Control
48.8 months
OS Gain
−2.2 months
OS HR
1.01 (0.84-1.23) OS NS (mature)

Adjustments

QoL Comment
No QoL benefit
Toxicity Comment
>10% incremental discontinuation due to AEs

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Comment
37.8% in the placebo arm received subsequent treatment with PARP inhibitors, possibly affecting OS results.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
214
Scorecard version
1
Issue date
26.10.2020
Last update
18.12.2024
Niraparib PRIMA/ENGOT-OV26/COG-3012

PRELIMINARY SCORE

PFS

ADJUSTMENTS

No QoL benefit
Niraparib PRIMA/ENGOT-OV26/COG-3012

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
3
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 for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based ChT
Niraparib
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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