A
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Melanoma
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour stage
- Adjuvant
- Control Arm
- Placebo
- Treatment Setting
- Adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB, IIC or III melanoma and who have undergone 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)
- QoL Comment
- QoL was not a prespecified endpoint
Final Score (after adjustments)
- Final curative score
- A
- Comment
- EMA (CHMP) May 2022 EC decision July 2022
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