Array’s Melanoma Drug Promising in Phase 2

Source: Drug, Discovery and Development, September 2014

Final results from a Phase 2 trial of binimetinib in patients with advanced NRAS mutant melanoma were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain.

Invented by Array BioPharma Inc. and licensed to Novartis in 2010, binimetinib is a small molecule selective inhibitor of the kinases MEK1 and MEK2.

Results from the 117 patient Phase 2 study showed median progression free survival (mPFS) of 3.6 months and objective response rate (ORR) of 14.5%, including one patient who achieved a complete response. These findings were consistent with previously disclosed interim results at the American Society of Clinical Oncology 2012 annual meeting. In addition, the median overall survival (mOS) of 12.2 months is encouraging for this patient population, which has a particularly poor prognosis. NEMO, a global phase 3 trial currently enrolling patients with NRAS mutant melanoma, is designed to measure the difference in PFS between patients treated with binimetinib versus those treated with dacarbazine, a current standard of care.

Adverse events in the Phase 2 study were generally mild to moderate. The most frequently observed adverse events included acneiform dermatitis, increased blood creatine phosphokinase and peripheral edema, which are consistent with previous results reported for the MEK inhibitor class.

“Patients with NRAS mutations have no targeted treatment available and prognosis is poor," said Reinhard Dummer, of the University of Zurich Hospital in Zurich, Switzerland. “These data reinforce our view that binimetinib is an important new potential treatment option for these patients and I look forward to seeing the results from the ongoing Phase 3 NEMO trial to validate these findings."