GSK reports Phase III data for Tafinlar, Mekinist combo

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said twice-daily Tafinlar dabrafenib plus once-daily Mekinist trametinib as first-line therapy for advanced or metastatic melanoma met the primary endpoint of improving progression-free survival (PFS) vs. Tafinlar alone in the Phase III COMBI-d (MEK115306) trial (p<0.05). The double-blind, placebo-controlled, international trial enrolled 423 patients with unresectable or metastatic melanoma with V600 BRAF mutations. GSK also plans to report data this year from the open-label Phase III COMBI-v trial (MEK116513) evaluating the combo for metastatic melanoma.

Earlier this month, FDA granted accelerated approval to a pair of sNDAs expanding the label for both Tafinlar and Mekinist to include their use in combination for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. FDA approved both drugs as monotherapies last May (see BioCentury Extra, Jan. 8). ...