Phase 3 Results for Tafinlar in Mutant Metastatic Melanoma

GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma. Tafinlar is a selective BRAF inhibitor that blocks tumor cell growth through inhibition of some mutated forms of BRAF, including the BRAFV600 mutation.

BREAK-3 (BRF113683) is a randomized, open-label study comparing the efficacy, safety, and tolerability of dabrafenib to dacarbazine in patients with advanced or metastatic melanoma who harbour a BRAF V600E mutation. Patients with previously untreated BRAF V600E mutation-positive metastatic melanoma were randomized to receive dabrafenib or dacarbazine. The primary endpoint of the study was progression-free survival (PFS).

Of those included in the dabrafenib arm, 45% were alive at two years compared to 32% of those who began treatment with dacarbazine.

Tafinlar is already approved as monotherapy for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test. In combination with trametinib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by a Food and Drug Administration-approved test.

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