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2

Indication details

Combined Agent(s)
Trastuzumab, fluoropyrimidine and platinum-containing ChT
Control Arm
Placebo + trastuzumab, fluoropyrimidine and platinum-containing ChT
Therapeutic Indication
First-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Gastric or gastroesophageal junction adenocarcinoma
Tumour Stage
Locally advanced unresectable or metastatic
Tumour Sub-Group
HER-2 positive
Trial Name
KEYNOTE-811
NCT Number
NCT03615326
Trial Phase
Phase III

Approval details

FDA Approval
FDA accelerated approval May 2021 FDA amended approval November 2023
EMA Approval
EMA (CHMP) July 2023 EC decision August 2023
Comment
EMA and FDA approval is limited to patients with CPS>1. This is supported by an exploratory subgroup analysis that is not eligible for ESMO-MCBS scoring the score generated is in the ITT population.

Primary Outcome(s)

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

Outcome Data

PFS Control
8.1 months
PFS Gain
1.9 months
PFS HR
0.73 (0.61-0.87)
OS Control
16.8 months
OS Gain
3.2 months
OS HR
Immature

Adjustments

QoL Comment
QoL was an exploratory endpoint

Final Score (after adjustments)

Preliminary non-curative score

2

Final non-curative score

2

Comment
This score was based on the 'ITT' cohort (n=698 patients), with 85% of the patients showing a PD-L1 CPS >=1.

PFS and OS values for patients showing a PDL-1 CPS of 1 or more: PFS control:7.3 months gain 3.6 months HR 0.71 (0.59-0.86) and OS control 15.7 months and gain 4.3 months with HR 0.81 (0.67-0.98). Significance boundary was not reached.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
318
Scorecard version
1
Issue date
16.03.2022
Last update
20.03.2024
Pembrolizumab KEYNOTE-811

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Pembrolizumab KEYNOTE-811

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
2
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 of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
Pembrolizumab + Trastuzumab, fluoropyrimidine and platinum-containing ChT
Placebo + trastuzumab, fluoropyrimidine and platinum-containing ChT

My watchlist

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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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