4
Indication details
- Combined Agent(s)
- Fluoropyrimidine + platinum-based combination ChT
- Control Arm
- ChT
- Therapeutic Indication
- First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with fluoropyrimidine and platinum-based combination ChT
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal squamous cell carcinoma
- Tumour Stage
- Advanced or metastatic
- Trial Name
- CheckMate 648
- NCT Number
- NCT03143153
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2022
- EMA Approval
- EMA (CHMP) February 2022. EC decision April 2022
- Comment
- FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients. EMA approval is restricted to patients with tumour cell PD-L1 expression of ≥1%
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS (ITT)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 10.7 months. 2-year OS: 19%
- OS Gain
- 2.1 months. 2-year OS gain: 10% (26% at risk at 2 years)
- OS HR
- 0.78 (99.1% CI 0.65-0.93)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
>10% increment in discontinuation due to adverse effects
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 344
- Scorecard version
- 1
- Issue date
- 07.09.2022
- 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.