Novartis landmark study of Tafinlarā? + Mekinistā? demonstrates durable survival benefit at five years in patients with BRAF mutation-positive metastatic melanoma
Novartis landmark study of Tafinlarā? + Mekinistā? demonstrates durable survival benefit at five years in patients with BRAF mutation-positive metastatic melanoma. Study is longest follow-up to date of a BRAF and MEK inhibitor combination therapy in patients with BRAF V600-mutant metastatic melanoma Study shows stable overall survival and progression-free survival lasting more than five years with consistent tolerability Initial data from separate Phase II trial of BRAF and MEK inhibitors showed positive results in BRAF V600-mutant melanoma patients with metastatic brain metastases - Novartis today announced results from a Phase II study showing a durable survival benefit for some patients with BRAF V600 mutation-positive metastatic melanoma (MM) when treated with the combination of Tafinlarā? (dabrafenib) + Mekinistā? (trametinib) . The findings from the landmark five-year analysis of the trial, BRF113220, represent the longest follow-up to date of a BRAF and MEK inhibitor combination therapy in this patient population, and were presented today at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstract #9505). A total of 162 patients received either Tafinlar monotherapy (150 mg BID) (n = 54) or the Tafinlar + Mekinist combination (150 mg BID/2 mg QD) (n = 54). After five years, 20 patients (37%) remain in the study, including seven (13%) in the Tafinlar monotherapy arm and 13 (24%) in the combination therapy arm, demonstrating that overall survival (OS) with combination therapy is superior to monotherapy.

