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+ Melanoma > Clinical Studies

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) clinical trials

TAFINLAR + MEKINIST has been studied in 3 Phase 3 trials: 2 vs BRAF inhibitor monotherapy and 1 vs placebo1-3

PHASE 3 TRIAL COMBI-AD STUDY

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

ELIGIBILITY REQUIREMENTS

STUDY ENDPOINTS

  • Primary endpoint was RFS
  • Secondary endpoints were OS, distant metastasis-free survival, freedom from relapse, and safety

PHASE 3 TRIAL COMBI-v STUDY

COMBI-v was an open-label, randomized phase 3 study that compared TAFINLAR + MEKINIST vs vemurafenib monotherapy1

COMBI-v phase 3 study: TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) vs vemurafenib monotherapy
COMBI-v phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs vemurafenib monotherapy

STUDY ENDPOINTS

  • Primary endpoint was OS
  • Secondary endpoints included:
    • PFS
    • ORR, DOR, and safety
       

Crossover was prohibited; however, at the time of the first OS analysis, the protocol was amended so that patients who were initially randomized to vemurafenib could cross over to receive TAFINLAR + MEKINIST because of the clear survival benefit.

PHASE 3 TRIAL COMBI-d STUDY

COMBI-d was a double-blind, randomized phase 3 study that compared TAFINLAR + MEKINIST vs TAFINLAR monotherapy2

COMBI-d phase 3 study: TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) vs TAFINLAR® monotherapy
COMBI-d phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs Tafinlar® monotherapy

STUDY ENDPOINTS

  • Primary endpoint was PFS
  • Secondary endpoints included:
    • OS
    • ORR, DOR, safety, and pharmacokinetics

Crossover was not allowed during the course of the study in order to preserve the integrity of the OS endpoint. However, after the 2-year OS data cutoff, crossover was subsequently allowed and may confound future OS analyses.

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With the largest trial database of efficacy and safety in BRAF+ patients, TAFINLAR + MEKINIST is the established leader in BRAF-targeted therapy.4

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BID, twice daily; cuSCC, cutaneous squamous cell carcinoma; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ERK, extracellular signal–regulated kinase; MEK, mitogen-activated protein kinase/extracellular signal–regulated kinase; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, once daily; RECIST, Response Evaluation Criteria In Solid Tumors; RFS, relapse-free survival.
References: 1. Robert C, Karaszewska B, Schachter J, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372(1):30-39. 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, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377(19):1813-1823. 4. Data on file. Novartis Pharmaceuticals Corp;  2018.

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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)
imgh22

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