Tafinlar+Mekinist Phase III trial meets endpoint in Melanoma-GSK

A Phase III study (COMBI-d) of the combination of Tafinlar (dabrafenib) and Mekinist (trametinib), from Glaxo Smith Kline, versus therapy with Tafinlar in patients with BRAF V600 E or K mutation positive unresectable or Metastatic Melanoma, has met its primary endpoint of Progression Free Survival (PFS). This follows the recent accelerated approval of the combined therapy in the USA.

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. In the combination arm, the most commonly reported (>20%) adverse events were pyrexia, fatigue, nausea, headache, chills, diarrhoea, arthralgia, rash, hypertension, and vomiting. Full study results will be presented at an upcoming scientific meeting.