1
Indication details
- Combined Agent(s)
- Fluoropyrimidine + platinum-containing ChT
- Control Arm
- Placebo + fluoropyrimidine + platinum-containing ChT
- FDA Therapeutic Indication
- Pembrolizumab with fluoropyrimidine and platinum-containing ChT for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Locally advanced unresectable or metastatic
- Tumour Sub-Group
- HER2-
- 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
Primary Outcome(s)
- Primary Outcome(s)
- OS (ITT)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 11.5 months
- OS Gain
- 1.4 months
- OS HR
- 0.78 (0.70 - 0.87)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 410
- Scorecard version
- 1
- Issue date
- 05.12.2023
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.