FDAnews Drug Daily Bulletin

GSK: Tafinlar/Mekinist Combo Met Phase III Endpoint

Jan. 27, 2014

A Phase III study of GlaxoSmithKline’s Tafinlar/Mekinist combination therapy met its primary endpoint of progression-free survival (PFS) in 423 patients with BRAF V600E or K mutation-positive unresectable or metastatic melanoma in four global regions, GSK revealed Friday.

Not only did results show increased PFS in Phase III, but they also showed greater PFS in patients given monotherapy than had previously been observed in a Phase I/II study, the drugmaker told Drug Daily Bulletin.

GSK is currently conducting a second Phase III randomized, open-label study comparing overall survival of rates of Mekinist (trametinib) and Tafinlar (dabrafenib) against Roche’s Zelboraf (vemurafenib). Results from this study are expected to come sometime this year.

The FDA last year approved both melanoma drugs as monotherapies, and earlier this month approved them in combination.

GSK also has a MAGE-A3 recombinant immunotherapeutic melanoma compound in Phase III. — Lena Freund

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