For Healthcare Professionals Outside the US
Tafinlar + Mekinist is indicated for adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection; for first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation; for adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

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Home > Efficacy > Metastatic BRAF V600+ Melanoma > Duration of response
For first-line targeted therapy in patients with BRAF V600 positive metastatic melanoma 

First-line TAFINLAR + MEKINIST demonstrated durable responses, with a median duration of response of 39.6 months in patients who achieved a CR in the COMBI-v trial1

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) duration of response
  • The majority of patients (53%) who achieved a CR on first-line TAFINLAR + MEKINIST remained in CR after a median follow-up of 23 months in the COMBI-v study1

In the 2 phase 3 studies, TAFINLAR + MEKINIST demonstrated durable responses, with median durations of response ranging from 12.9 to 13.8 months1,2

Duration of response phase 3 studies TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)
  • In COMBI-v, the median duration of response with TAFINLAR + MEKINIST was 13.8 months compared with 7.9 months with vemurafenib1
  • In COMBI-d, the median duration of response with TAFINLAR + MEKINIST was 12.9 months compared with 10.6 months with TAFINLAR monotherapy2
CR, complete response.
References: 1. Robert C, Karaszewska B, Schachter J, et al. Three-year estimate of overall survival in COMBI-v, a randomized phase 3 study evaluating first-line dabrafenib + trametinib in patients with unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma. Presented at: European Society for Medical Oncology; October 7-11, 2016; Copenhagen, Denmark. 2. Long GV, Stroyakovskiy D, Gogas H, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015;386(9992):444-451.

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04/20  G-ONC-1230566

COMBI-AD was a double-blind, placebo-controlled, Phase 3 trial that compared Tafinlar + Mekinist vs placebo4

ELIGIBILITY REQUIREMENTS

  • Resection of histologically confirmed Stage IIIA, B, or C with BRAF V600E or BRAF V600K mutation
  • ECOG performance status ≤1
  • No prior systemic anticancer treatment or radiotherapy for melanoma
TAFINLAR 150 mg BID + MEKINIST
2 mg QD (n=438)
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Placebo (n=432)

STUDY ENDPOINTS

  • Primary endpoint was RFS
  • Secondary endpoints were OS, distant metastasis-free survival, freedom from relapse, and safety
COMBI-d phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs Tafinlar® monotherapy