Array BioPharma announced in a press release that an ongoing phase 3 trial of binimetinib in patients with advanced NRAS-mutant melanoma met primary endpoint of improving progression free-survival when compared with dacarbazine treatment.
“The presence of an NRAS mutation is a poor prognostic indicator for patients with advanced melanoma,” Keith T. Flaherty, MD, associate professor of medicine, Harvard Medical School and director of developmental therapeutics, Cancer Center, Massachusetts General Hospital, said in the release. “As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition to this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy.”
In the international study, there were 402 patients randomized 2:1 to receive continuous 45 BID binimetinb, a small molecule MEK inhibitor, or 1,000 mg/m2 dacarbazine dosing every three weeks. Overall survival was key secondary endpoint.
The median progression-free survival (PFS) in patients treated with binenimetinb was 2.8 month compared with 1.5 months for patients treated with dacarbazine (hazard ratio = 0.62; 95% CI, 0.47-0.80), according to the release.
Treatment was generally well-tolerated with adverse effects reported being consistent with previous results for patients with NRAS-mutant melanoma, the release reported.
Array stated in the release that it plans to submit binimetinb for marketing approval in NRAS-mutant melanoma in the first half of 2016. Trial results including PFS, overall survival, objective response rate, safety and prescribed subgroup analyses are to be presented at a 2016 medical meeting, according to the release.