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3

Indication details

Combined Agent(s)
Cisplatin and 5-FU
Control Arm
Placebo + cisplatin and 5-FU
Therapeutic Indication
First-line treatment locally advanced or metastatic oesophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive CRT in combination with platinum- and fluoropyrimidine-based ChT
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Oesophageal or gastroesophageal carcinoma
Tumour Stage
Locally advanced or metastatic
Tumour Sub-Group
HER2- GEJ (all randomized)
Trial Name
KEYNOTE-590
NCT Number
NCT03189719
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval March 2021 FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

PFS Control
5.8 months
PFS Gain
0.5 months
PFS HR
0.65 (0.55-0.76)
OS Control
9.8 months
OS Gain
2.6 months - 12% improvement at 2-years but <10% of patients still on follow up by that time
OS HR
0.73 (0.62-0.86)

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Comment
FDA approval March 2021

FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
308
Scorecard version
1
Issue date
10.12.2021
Pembrolizumab KEYNOTE-590

PRELIMINARY SCORE

OS

ADJUSTMENTS

Pembrolizumab KEYNOTE-590

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
3
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Gastrointestinal Cancers
First-line treatment locally advanced or metastatic oesophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive CRT in combination with platinum- and fluoropyrimidine-based ChT
Pembrolizumab + Cisplatin and 5-FU
Placebo + cisplatin and 5-FU

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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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