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A

Indication details

Control Arm
Placebo
Therapeutic Indication
Adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB, IIC or III melanoma and who have undergone complete resection
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Melanoma
Tumour Stage
Adjuvant
Trial Name
KEYNOTE-054
NCT Number
NCT02362594
Trial Phase
Phase III

Approval details

EMA Approval
EMA (CHMP) May 2022 extension to an existing indication EC decision July 2022 previous approval EMA (CHMP) October 2018 EC decision December 2018
Comment
EMA previous therapeutic indication: adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection. The extension to this existing indication combines two trials KEYNOTE-054 and KEYNOTE-716 (reported in scorecard 339-1)

Primary Outcome(s)

Primary Outcome(s)
RFS
Evaluated Outcome
RFS
Form(s)
Form 1

Outcome Data

RFS Control
1-year 61%
RFS Gain
1-year 14.4%
RFS HR
056 (0.47-0.68)

Adjustments

Toxicity Comment
Higher incidence of acute and persisting adverse effects

Final Score (after adjustments)

Final curative score

A

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
173
Scorecard version
1
Issue date
09.06.2020
Last update
03.11.2023
Pembrolizumab KEYNOTE-054

PRELIMINARY SCORE

DFS

ADJUSTMENTS

Pembrolizumab KEYNOTE-054

FINAL SCORE

A

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Skin Cancers
Adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB, IIC or III melanoma and who have undergone complete resection
Pembrolizumab
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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