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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

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