Tafinlar dabrafenib: Phase III data

The double-blind, placebo-controlled, international Phase III COMBI-d trial (MEK115306) in 423 patients with unresectable or metastatic melanoma with V600 BRAF mutations showed that twice-daily 150 mg Tafinlar dabrafenib plus once-daily 2 mg Mekinist trametinib as first-line therapy met the primary endpoint of improving PFS vs. Tafinlar alone (p<0.05). GlaxoSmithKline said the PFS, response rate and interim OS data for the combination arm were consistent with data reported last May from a Phase I/II trial of the combination in the indication (see BioCentury, June 3, 2013). GSK will present detailed data at an upcoming scientific meeting.

This year, GSK plans to report data from the open-label, international Phase III COMBI-v trial (MEK116513) evaluating the combination in metastatic melanoma. The primary endpoint of COMBI-v is OS. Earlier this month, FDA granted accelerated approval to a pair of sNDAs expanding the label of each drug to include combination use of Tafinlar and Mekinist to treat adults with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test (see BioCentury, Jan. 13). FDA approved both drugs as monotherapies last May; GSK has launched both in the U.S. (see BioCentury, June 3, 2013). ...