4
Indication details
- Control Arm
- ChT
- Therapeutic Indication
- First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with ipilimumab
- 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
- 2.0 months. 2-year OS gain: 13% (30% at risk at 2 years)
- OS HR
- 0.77 (98.2% CI 0.65-0.92)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 345
- Scorecard version
- 1
- Issue date
- 07.09.2022
- Last update
- 26.11.2024