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Combo Therapy Meets Main Goal in Melanoma Trial
A phase III study of the combination of dabrafenib (Tafinlar) and trametinib (Mekinist), compared with single-agent therapy with dabrafenib in patients with BRAF V600 E or K mutation-positive unresectable or metastatic melanoma, has met its primary endpoint of progression-free survival (PFS) (P < 0.05).The new findings follow the recent accelerated approval of the combined therapy in the U.S.
The COMBI-d trial was a phase III, randomized, double-blind study comparing the combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib with dabrafenib and placebo as first-line therapy in patients with unresectable (stage IIIC) or metastatic (stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The study enrolled a total of 423 patients in North and South America, Europe, and Australia.
PFS 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 a previous phase I/II study.
In the combination arm, the most commonly reported adverse events were pyrexia, fatigue, nausea, headache, chills, diarrhea, arthralgia, rash, hypertension, and vomiting.
Both dabrafenib and trametinib are marketed by GlaxoSmithKline.
Source: GSK; January 24, 2014.