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Dab/Tram (dabrafenib and trametinib)

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

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