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+ NSCLC > Biomarker testing

Biomarker identification can aid therapy selection for patients with metastatic non-small cell lung cancer (mNSCLC)1,2

ESMO and ASCO guidelines recommend testing for BRAF in mNSCLC1,2

In 4 patients with mNSCLC have actionable mutations
BRAF is a driver mutation: EGFR, ALK rearrangement, HER2, MET, ROS1, RET
  • Upfront biomarker testing can help determine actionable targets1,2
  • Up to 2% of patients with NSCLC have BRAF V6004-7
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Employ broad biomarker testing to identify patients with an actionable mutation3

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ESMO, European Society for Medical Oncology; ASCO, American Society of Clinical Oncology.   
References: 1. 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. 2. Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline update. J Clin Oncol. 2018;36(9):911-919. 3. Korpanty GJ, Graham DM, Vincent MD, Leighl NB. Biomarkers that currently affect clinical practice in lung cancer: EGFR, ALK, MET, ROS-1, and KRAS. Front Oncol. 2014;4:204. doi:10.3389/fonc.2014.00204. 4. Marchetti A, Felicioni L, Malatesta S, et al. Clinical features  and outcome of patients with non–small-cell lung cancer harboring BRAF mutations. J Clin Oncol. 2011;29(26):3574-3579. 5. Cardarella S, Ogino A, Nishino M, et al. Clinical, pathologic, and biologic features associated with BRAF mutations in non-small cell lung cancer. Clin Cancer Res. 2013;19(16):4532-4540. 6. Paik PK, Arcila ME, Fara M, et al. Clinical characteristics of patients with lung adenocarcinomas harboring BRAF mutations. J Clin Oncol. 2011;29(15):2046-2051. 7. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006.

COVID-19 Update


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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