Combination Targeted Therapy Improves Survival in BRAF+ Metastatic Melanoma

MedicalResearch.com Interview with:
Jeff Legos
Senior Vice President
Global Program Head
Novartis Oncology

Medical Research: What is the background for this study? What are the main findings?

Response: Melanoma is the most serious form of skin cancer, and in recent years, research has discovered that melanoma is a diverse disease. In metastatic melanoma, approximately half of all patients have a mutation in the BRAF gene, and genetic testing can identify whether BRAF mutations are present in a tumor. Identifying a mutation can help doctors determine the appropriate treatment to treat BRAF-positive melanoma.

Since January 2014, the combination of Tafinlar + Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was initially approved based on Phase II data through the FDA’s Accelerated Approval program and reviewed under a priority review designation. The approval was contingent on the results of the Phase III COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation. The regular approval is based on survival data from two Phase III studies: COMBI-d and COMBI-v. These studies showed that Tafinlar + Mekinist demonstrated statistically significant overall survival (OS) and progression-free survival (PFS) compared with dabrafenib or vemurafenib, in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma.

In addition, combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the EU, Australia, Canada and additional countries.

Medical Research: What should clinicians and patients take away from your report?

Response: Metastatic melanoma is associated with low survival rates. Only about 20% of people will survive for at least five years following a diagnosis with late-stage disease. The combination of Tafinlar + Mekinist offers hope for patients with BRAF V600E/K-mutant metastatic melanoma, having demonstrated a confirmed median overall survival of more than two years.

Medical Research: What recommendations do you have for future research as a result of this study?

Response: The combination of Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide. The combo is currently being evaluated in a phase III study as adjuvant treatment for patients with BRAF V600 stage III respectable melanoma. We are also evaluating Taf/Mek in combinations with immunotherapy. We are focused on combination treatments that can help patients, and we are working to make our medicines available to those in need now and in the future.

Citation:

Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data

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Jeff Legos (2015). Combination Targeted Therapy Improves Survival in BRAF+ Metastatic Melanoma 

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