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Scorecard version: 1

Indication details

Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Oesophageal Cancer
Tumour stage
Advanced or metastatic
Control Arm
Treatment Setting
First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with ipilimumab
Trial Name
CheckMate 648

Primary Outcome(s)

Primary Outcome(s)
Evaluated Outcome
Form 2a

Outcome Data

OS Control
10.7 months
OS Gain
2.0 months
0.78 (98.2% CI 0.62-0.98)

Final Score (after adjustments)

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

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

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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