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 > Adjuvant BRAF V600+ Melanoma > Relapse-Free Survival
For the adjuvant treatment of Stage III BRAF V600 positive melanoma following complete resection

In COMBI-AD, TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) reduced the risk of relapse or death by nearly 50%1-5

12 months of therapy kept over 50% of adjuvant patients with melanoma relapse-free at 5 years1,2

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) reduced the risk of relapse or death by nearly 50%
*11-month median duration of exposure to TAFINLAR + MEKINIST. 
Estimated RFS rates for years 1-3 at a median follow-up time of 2.8 years.2 
  • In COMBI-AD, the median duration of follow-up for updated analysis was 60 months for TAFINLAR + MEKINIST arm and 58 months for the placebo arm1 
  • In COMBI-AD, primary analysis was positive for RFS, with HR of 0.47 (0.39, 0.58) P=0.0000000000000153 (34-month median follow-up)1,3 

Consistent RFS benefits across a wide range of patients and disease characteristics

Hazard ratio for RFS, according to subgroup1

TAFINLAR® + MEKINIST® reduced the risk of relapse or death by nearly 50%
TAFINLAR® + MEKINIST® reduced the risk of relapse or death by nearly 50%
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Treat your patients with confidence regardless of substage or other prognostic factors.

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CI, confidence interval; HR, hazard ratio; RFS, relapse-free survival. 

References: 1. Dummer R, Hauschild A, Santinami M, et al. Five-year analysis of adjuvant dabrafenib plus trametinib in stage III melanoma. N Engl J Med. 2020;383(12):1139-1148. 2. 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. 3. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 4. Hauschild A, Dummer R, Santinami M, et al. Long-term benefit of adjuvant dabrafenib plus trametinib in patients with resected stage III BRAF V600–mutant melanoma: 5-year analysis of COMBI-AD. Presented at: 2020 ASCO Annual Meeting, May 29-31, 2020; Chicago, IL. 5. Hauschild A, Dummer R, Schadendorf D, et al. Longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600–mutant stage III melanoma. J Clin Oncol. 2018. doi:10.1200 /JCO.18.01219.

COVID-19 Update


Novartis is closely monitoring the evolving COVID-19 pandemic. For the most recent information on how Novartis is responding, visit the COVID-19 Information Center.

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.

Reach out to your Novartis representative with any questions related to Novartis products.

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