Positive results from COMBI-v study of Mekinist and Tafinlar

Results published in the New England Journal of Medicine show that treatment with the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) significantly improved overall survival (OS) compared to vemurafenib monotherapy in previously untreated patients with BRAF V600E/K mutation-positive metastatic melanoma, without increased overall toxicity.

The US Food and Drug Administration approved UK pharma major GlaxoSmithKline’s (LSE: GSK) combination of Mekinist for use in combination with Tafinlar early this year for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations (The Pharma Letter January 9).

The new COMBI-v study demonstrated a 31% decrease in the risk of death for patients treated with the trametinib and dabrafenib combination compared to vemurafenib (Hazard Ratio [HR] 0.69; 95% Confidence Interval [CI] 0.53, 0.89; two-sided P=0.005). Median OS for the vemurafenib arm was 17.2 months; median OS for the combination arm had not been reached. At 12 months, the rate of OS was 72% for the combination arm and 65% for the vemurafenib arm.