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 > About > BRAF V600+ NSCLC > Clinical study

TAFINLAR + MEKINIST: An approved combination therapy for advanced NSCLC with a BRAF V600 mutation1,2

Efficacy and safety established in a Phase II, 3-cohort, multicenter, non-randomized, open-label study1,2

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) phase 2 study treatment-naïve and previously treated patient cohorts
 TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) phase 2 study treatment-naïve and previously treated patient cohorts
  • Primary End Point: Overall response rate (ORR) using RECIST 1.1 assessed by the investigator1-3
  • Secondary End Points: Duration of response (DoR), progression-free survival (PFS), and overall survival (OS)1-3

Baseline patient characteristics in the phase II trial (cohorts B and C) 

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) phase 2 study baseline characteristics
TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) phase 2 study baseline characteristics
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Occurrence of BRAF V600 mutation supports broad biomarker testing

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References: 1. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 2. Mekinist Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 3. Planchard D, Besse B, Groen HJM, et al. Dabrafenib plus trametinib in patients with previously treated BRAFV600E-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016;17(7):984-993. 4. Tafinlar [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.

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During this time of uncertainty it is important to communicate with your patients about COVID-19 to clarify that they should not stop their treatments except under the direction of the treating physician, and to ensure that patients have sufficient drug to avoid any treatment interruptions.

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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