GSK announces positive results for combined Tafinlar, Mekinist treatment for metastatic melanoma

GlaxoSmithKline announced overall survival results from a phase 3 study that demonstrated a statistically significant reduction in the risk of death with a combination of Tafinlar and Mekinist compared with Tafinlar monotherapy in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma.

The combination of Tafinlar (dabrafenib), a BRAF inhibitor, and Mekinist (trametinib), an MEK inhibitor, had a hazard ratio (HR) of 0.71 compared with dabrafenib monotherapy for reduction in risk of death, according to a press release. The safety profile was consistent with previous data for the combination of drugs.

Study completion is a post-marketing requirement for the FDA’s accelerated approval for the combination of dabrafenib and trametinib. Final study data will be submitted to regulatory authorities in the near future, the release stated.

The study included 423 patients from Australia, Europe, and North and South America with unresectable (stage III C) or metastatic (stage IV) BRAF V600E/K mutation-positive cutaneous melanoma who were randomly assigned to treatment with the combination of dabrafenib and trametinib or dabrafenib and placebo. Primary endpoint of the study was investigator-assessed progression-free survival.

In a previous analysis from August 2013, treatment with the drug combination resulted in a 25% reduction in the risk of disease progression and/or death compared with dabrafenib alone (HR = 0.75%), according to the release.

The most common adverse events (≥ 20%) during primary analysis were pyrexia, fatigue, headache, nausea, chills, arthralgia, diarrhea, rash, hypertension and vomiting.

The combination of dabrafenib and trametinib for treating patients with unresectable or metastatic melanoma with BRAF V600EK mutation is approved in the U.S. and Australia, according to the release.

Reference: www.gsk.com.