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 > BRAF V600+ NSCLC > Efficacy results

TAFINLAR + MEKINIST: An approved targeted therapy indicated for BRAF V600 metastatic non-small cell lung cancer (mNSCLC)

Combination TAFINLAR + MEKINIST: Efficacy results in first-line, treatment-naïve patients and second-line, previously treated patients with BRAF V600+ mNSCLC (investigator and IRC assessed)1,2 

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) efficacy results in treatment-naïve patients.
TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) efficacy results in previously treated patients.

At 3 years, TAFINLAR + MEKINIST demonstrated durable responses and overall survival benefit in patients with BRAFV600+ mNSCLC, regardless of prior treatment4,5

Updated 3-year analysis (As of June 2019)

3-year analysis_ORR_Median PFS
OS Previously Treated Line Graph
OS Treatment Naive Line Graph

33% of pre-treated patients and 40% of treatment-naïve patients were still alive at 3 years5

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ESMO clinical guidelines recommend TAFINLAR + MEKINIST as first-line treatment for BRAF V600+ patients with advanced NSCLC6

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DoR, duration of response; IRC, independent review committee; NA, not available; NE, not evaluable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.
References: 1. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 2. Mekinist Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 3. Planchard D, Smit EF, Groen HJM, et al. Dabrafenib plus trametinib in patients with previously untreated BRAFV600E-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial [published online September 8, 2017]. Lancet Oncol. doi:10.1016/S1470-2045(17)30679-4. 4. Planchard D, Besse B, Groen HJM, et al. Updated survival and genomic analysis from a single-arm phase 2 study of dabrafenib plus trametinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer. Presented at: ASCO Virtual Meeting; May 21-31, 2020. 5. Data on file (Planchard manuscript); Novartis Pharmaceuticals Corp; 2020. 6. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Ann Oncol. 2018;29(suppl4):iv192-iv237.doi:10.1093/annonc/mdy275.

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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