GSK stops melanoma trial early on interim data

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said an interim analysis by an independent DMC showed Tafinlar dabrafenib plus Mekinist trametinib met a prespecified threshold of improving overall survival (OS), the primary endpoint, vs. Zelboraf vemurafenib from Roche (SIX:ROG; OTCQX:RHHBY) in the Phase III COMBI-v (MEK116513) trial to treat unresectable or metastatic cutaneous melanoma in patients with V600E or V600K BRAF mutations. As a result, the open-label trial -- which had enrolled 704 patients with stage IIIC or stage IV BRAF V600E or V600K mutation-positive melanoma -- was stopped early. GSK said the analysis occurred when about 70% of the total deaths required for the final analysis were observed across both arms. GSK said it will report additional data "over the coming months."

Tafinlar and Mekinist are approved as monotherapies in the EU and U.S., and in combination in the U.S. In March, GSK withdrew an MAA for Tafinlar in combination with Mekinist to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation. According to the pharma, EMA's CHMP could not "conclude on a positive benefit-risk balance of the combination" based on data provided by GSK. The pharma said it plans to resubmit the MAA based on data from the Phase III COMBI-v and COMBI-d trials, but declined to disclose a timeline. ...