4
Indication details
- Combined Agent(s)
- Fluoropyrimidine + platinum-containing ChT
- Control Arm
- Placebo + fluoropyrimidine + platinum-containing ChT
- Therapeutic Indication
- Pembrolizumab in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal 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
- HER2-, PD-L1 with a CPS ≥1*
- Trial Name
- KEYNOTE-859
- NCT Number
- NCT03675737
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2023
- EMA Approval
- EMA (CHMP) October 2023 EC decision December 2023
- Comment
- FDA approval is irrespective of PD-L1 status
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 11.4 months - 2-year 18%
- OS Gain
- 1.6 months - 2-year 12%. <20% of patients on exploratory arm evaluable at 24 months
- OS HR
- 0.74 (0.65-0.84)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Non-curative score
-
4
- Comment
-
*In the ITT population, 1235 participants (78%) had tumours with a PD-L1 CPS
of 1 or higher
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 400
- Scorecard version
- 1
- Issue date
- 17.11.2023
- Last update
- 26.11.2024
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.