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 > Overall Response rate
For first-line targeted therapy in patients with BRAF V600 positive metastatic melanoma

In 2 phase 3 studies, up to 69% of patients experienced complete or partial responses with first-line TAFINLAR + MEKINIST 1,2

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

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  • 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%
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. 

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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