4
Indication details
- Combined Agent(s)
- Fluoropyrimidine and platinum ChT (FOLFOX or CAPOX)
- Control Arm
- ChT (FOLFOX or CAPOX)
- FDA Therapeutic Indication
- First‑line treatment for patients with HER2‑negative advanced or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a CPS ≥5
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction cancer and oesophageal adenocarcinoma
- Tumour Stage
- Advanced or metastatic
- Tumour Sub-Group
- HER2- PD-L1 CPS ≥5
- Trial Name
- CheckMate 649
- NCT Number
- NCT02872116
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) September 2021 EC decision October 2021
- Comment
- EMA approval is restricted to patients whose tumours express PD-L1 with a CPS of ≥5 and so data shown are for this subgroup of patients.
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 11.1 months
- OS Gain
- 3.3 months
- OS HR
- 0.70 (0.61-0.81)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 290
- Scorecard version
- 1
- Issue date
- 17.09.2021
- Last update
- 28.11.2023
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.