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3
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Oesophageal Cancer
Tumour stage
Advanced or metastatic
Combined Agent(s)
Fluoropyrimidine and platinum-based combination ChT
Control Arm
ChT
Treatment Setting
First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with fluoropyrimidine and platinum-based combination ChT
Trial Name
CheckMate 648

Primary Outcome(s)

Primary Outcome(s)
OS/PFS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
10.7 months
OS Gain
2.5 months
OS HR
0.74 (99.1% CI 0.58-0.96)

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Comment
FDA approval May 2022

FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.
Issue date
07.09.2022
Release date
07.09.2022

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

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