GSK’s Tafinlar and Mekinist combo shows improved survival in Phase III study

UK pharma major GlaxoSmithKline (LSE: GSK) announced that its Phase III study of the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with unresectable or metastatic melanoma met its primary endpoint of progression free survival.

This follows the accelerated approval of the combined therapy in the USA earlier this month. Progression free survival, response rate and interim overall survival results for the combination arm were consistent with those seen in the Phase I/II study. In this Phase III study, PFS observed among patients in the single agent dabrafenib arm was greater than that seen in previous single agent dabrafenib studies, leading to a more modest difference in PFS between treatment arms than was observed in the Phase I/II study. Full study results will be presented at an upcoming scientific meeting.

Rafael Amado, senior vice president of oncology R&D at GSK, said: “We are pleased to report that the first of our Phase III studies investigating the combination of Tafinlar and Mekinist met its primary endpoint. These results, along with data we expect to receive later in the year from our Phase III study comparing the combination to vemurafenib, will increase the body of evidence on the safety and efficacy of this combination in appropriate patients with melanoma.”