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4
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Skin Cancers
Tumour Sub-type
Melanoma
Tumour stage
Advanced unresectable or metastatic
Control Arm
Ipilimumab
Treatment Setting
Treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma
Trial Name
KEYNOTE-006

Primary Outcome(s)

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

Outcome Data

OS Control
16.0 months
OS Gain
7.5 months (Calculated estimate of gain based on PE HR 0.68)
OS HR
0.68 (0.53-0.86)*
QoL Comment
Exploratory endpoint not eligible for scoring

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
Comment
EMA (CHMP) May 2022 extension to an existing indication pending EC decision
EMA (CHMP) May 2015 EC decision July 2015
FDA approval March 2015

*Reported HR is for the 3-week schedule of pembrolizumab
Issue date
19.04.2022
Release date
19.04.2022
Last update
31.05.2022

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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