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3

Indication details

Control Arm
Investigator-choice chemotherapy (Randomised phase II study)
Therapeutic Indication
Adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Melanoma
Tumour Stage
Advanced unresectable or metastatic
Trial Name
KEYNOTE-002
NCT Number
NCT01704287
Trial Phase
Phase II

Primary Outcome(s)

Primary Outcome(s)
PFS 2 mg/kg
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
2.7 months
PFS Gain
0.2 months
PFS HR
0.57 (0.45-0.73) plateau PFS gain >10% at 1 year

Adjustments

QoL Comment
QoL was an exploratory endpoint

Final Score (after adjustments)

Preliminary non-curative score

2

Long-term plateau in the PFS curve
1+
Final non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
91
Scorecard version
1
Issue date
11.12.2018
Last update
16.01.2023
Pembrolizumab KEYNOTE-002

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Long term plateau in the PFS curve
Pembrolizumab KEYNOTE-002

FINAL 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
Skin Cancers
Adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma
Pembrolizumab
Investigator-choice chemotherapy (Randomised phase II study)

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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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