For Healthcare Professionals Outside the US

For patients with BRAF V600 mutation–positive unresectable or metastatic melanoma

For patients with BRAF V600 mutation–positive advanced non-small cell lung cancer (NSCLC)

In 2 phase 3 studies, up to 69% of patients experienced complete or partial responses with first-line Tafinlar + Mekinist1,2

Overall response rate of Tafinlar® (dabrafenib) + Mekinist® (trametinib)

  • Greater than 90% of patients achieved disease control with first-line Tafinlar + Mekinist1,2
  • The ORR in patients who received Tafinlar + Mekinist ranged from 67% to 69% compared with 53% in those who received Tafinlar monotherapy or vemurafenib monotherapy1,2
  • Tafinlar + Mekinist has a low rate of primary resistancea (6%)1,2

a Primary resistance is defined as best response to therapy being progressive disease.

In a post hoc analysis across the 3 randomized studies, Tafinlar + Mekinist demonstrated high response rates even in patients with elevated LDH levels at baseline3

Response rates in patients with elevated lactate dehydrogenase (LDH) levels at baseline

  • Data from the patients who received Tafinlar + Mekinist across the 3 randomized studies were pooled3
    • In patients with normal LDH levels at baseline, the ORR was 74%
    • In patients with LDH levels of > 1 to ≤ 2 × ULN at baseline, the ORR was 59%
    • In patients with LDH levels of > 2 × ULN at baseline, the ORR was 51%

The use of Tafinlar + Mekinist after progression on BRAF inhibitor monotherapy resulted in inferior responses compared with first-line usage4-6

Tafinlar® (dabrafenib) + Mekinist® (trametinib) overall response rate by type

  • The randomized 220 study demonstrated that first-line use of Tafinlar + Mekinist resulted in much higher responses compared with using Tafinlar + Mekinist postprogression in patients who progressed on BRAF inhibitor monotherapy. Based on this limited data, Tafinlar + Mekinist should be used prior to disease progression on a BRAF inhibitor4-6

CR, complete response; LDH, lactate dehydrogenase; ORR, overall response rate; PR, partial response; ULN, upper limit of normal.

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. 3. Long GV, Grob JJ, Nathan P, et al. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomized trials. Lancet Oncol. 2016;17(12):1743-1754. 4. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2017. 5. Flaherty KT, Infante JR, Daud A, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012;367(18):1694-1703. 6. Johnson DB, Flaherty KT, Weber JS, et al. Combined BRAF (dabrafenib) and MEK inhibition (trametinib) in patients with BRAF V600-mutant melanoma experiencing progression with single-agent BRAF inhibitor. J Clin Oncol. 2014;32(33):3697-3704.