4
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal Cancer
- Tumour Sub-Group
- PD-L1 expression ≥1%
- Tumour stage
- Unresectable advanced, recurrent or metastatic
- Combined Agent(s)
- Fluoropyrimidine and platinum-based combination ChT
- Control Arm
- ChT
- Treatment Setting
- First-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%
- Trial Name
- CheckMate 648
Primary Outcome(s)
- Primary Outcome(s)
- OS/PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 9.1 months
- OS Gain
- 6.3 months
- OS HR
- 0.54 (99.5% CI 0.37-0.80)
Final Score (after adjustments)
- Preliminary non-curative score
- 4
- Final non-curative Score
- 4
- Comment
- EMA (CHMP) February 2022 EC decision April 2022
- Issue date
- 31.03.2022
- Release date
- 31.03.2022
- Last update
- 21.04.2022
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type