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A
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Skin Cancers
Tumour Sub-type
Melanoma
Tumour stage
Adjuvant
Control Arm
Placebo
Treatment Setting
Adjuvant treatment of patients with stage IIB or IIC melanoma following complete resection
Trial Name
KEYNOTE-716

Primary Outcome(s)

Primary Outcome(s)
RFS
Evaluated Outcome
RFS
Form(s)
Form 1

Outcome Data

RFS Control
77% at 18 months
RFS Gain
9.0%
RFS HR
0.61 (0.45-0.82)

Final Score (after adjustments)

Final curative score
A
Comment
FDA approval December 2021
Issue date
30.05.2022
Release date
30.05.2022

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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