3
Indication details
- Combined Agent(s)
- Trastuzumab, fluoropyrimidine + platinum-containing ChT
- Control Arm
- Placebo + trastuzumab, fluoropyrimidine + platinum-containing ChT
- Therapeutic Indication
- EMA: Pembrolizumab for the 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. FDA: Pembrolizumab in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (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. FDA traditional approval, March 2025
- 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 (ITT)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
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
- 0.80 (0.67- 0.94) P = 0.004
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
This score was based on the 'ITT' cohort (n=698 patients), with 85% of the patients showing a PD-L1 CPS >=1.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 318
- Scorecard version
- 1
- Issue date
- 16.03.2022
- Last update
- 18.04.2025
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.