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3

Indication details

Control Arm
Single arm cohort study (Phase II)
Therapeutic Indication
Treatment of MSI-H or dMMR tumours in adults with unresectable or metastatic small intestine cancer, who have disease progression on or following at least one prior therapy.
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Small intestine
Tumour Stage
Unresectable or metastatic
Tumour Sub-Group
dMMR or MSI-H
Trial Name
KEYNOTE-158
NCT Number
NCT02628067
Trial Phase
Phase II

Approval details

EMA Approval
EMA (CHMP) March 2022 EC decision May 2022

Primary Outcome(s)

Primary Outcome(s)
ORR
Evaluated Outcome
ORR
Form(s)
Form 3

Outcome Data

PFS Control
9.2 months
OS Control
Not reached
ORR
42.10%
DoR
>9 months

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Comment
EMA (CHMP) March 2022 pending EC decision

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
334
Scorecard version
1
Issue date
28.04.2022
Pembrolizumab KEYNOTE-158

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Pembrolizumab KEYNOTE-158

FINAL SCORE

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
3
Overall Response Rate / Duration of Response
Gastrointestinal Cancers
Treatment of MSI-H or dMMR tumours in adults with unresectable or metastatic small intestine cancer, who have disease progression on or following at least one prior therapy.
Pembrolizumab
Single arm cohort study (Phase II)

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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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