The London-based company, GSK has stared a phase III trial called “COMBI-AD” that will test the combination of a BRAF and MEK inhibitor, dabrafenib and trametinib in patients with BRAF V600E mutation-positive melanoma who have had surgery to remove their tumors (adjuvant setting). The placebo-controlled trial is testing how long the combo treatment can delay or prevent cancer recurrence in these high-risk patients. Two phase III combination trials are currently ongoing to test the combination versus monotherapy in metastatic BRAF-positive melanoma patients.
The European Medicines Agency has granted a speedy review of trametinib, an experimental MEK inhibitor made by pharmaceutical company GlaxoSmithKline. The firm’s application for a European license includes findings from two studies of melanomas that have BRAF V600 mutations: a phase III trial comparing trametinib to two standard chemotherapy drugs (dacarbazine and paclitaxel) and a phase I/II trial comparing trametinib alone and in combination with the experimental BRAF-inhibitor dabrafenib. If approved, trametinib could be available to people with melanoma within 6 months.