5
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Skin Cancers
- Tumour Sub-type
- Melanoma
- Tumour Sub-Group
- BRAF V600E
- Tumour stage
- Metastatic
- Control Arm
- Vemurafenib
- Treatment Setting
- 1st line unresectable or metastatic melanoma with the BRAF V600E mutation
- Trial Name
- COMBI-v
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 7.3 months
- PFS Gain
- 4.1 months
- PFS HR
- 0.56 (0.46-0.69)
- OS Control
- 18.0 months* 3-years survival 31%
- OS Gain
- 8.0 months * 3-years survival 13%
- OS HR
- 0.69 (0.53-0.89) Interim OS (p=0.005<0.02)
- QoL Comment
- 17% reduction skin cancer
- Toxicity Comment
- Improved QoL (exploratory outcome) **
Final Score (after adjustments)
- Preliminary non-curative score
- 4
- Toxicity adjustment
- 1+
- Final non-curative Score
- 5
- Comment
- * Estimated from Kaplan-Meier plot. ** QoL evaluated as an exploratory endpoint (as distinct from primary or secondary endpoint) is not eligible for ESMO-MCBS grading.
- Last update
- 23.07.2020
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression