Phase III NEMO trial of MEK 162 (binimetinib) meets endpoint in NRAS-mutant melanoma patients- Array BioPharma

Array BioPharma announced data from the pivotal Phase III NEMO trial of MEK 162 (binimetinib) in NRAS-mutant melanoma patients. The study found binimetinib significantly extended median progression-free survival (PFS), the study's primary endpoint, at 2.8 months, as compared with 1.5 months observed with dacarbazine � the first trial to ever meet a PFS endpoint in patients with advanced NRAS-mutant melanoma.

In the pre-specified subset of patients who received prior treatment with immunotherapy, including ipilimumab, nivolumab or pembrolizumab, patients who received binimetinib experienced 5.5 months of median PFS, compared with 1.6 months for those receiving treatment with dacarbazine. In addition to improving PFS, binimetinib also demonstrated significant improvement in overall response rate (ORR) and disease control rate (DCR). While there was no statistically significant difference demonstrated in overall survival, the median overall survival (mOS) favored the binimetinib arm. Confirmed ORR was 15 percent in patients receiving binimetinib vs. 7 percent in patients receiving dacarbazine.DCR for patients receiving binimetinib was 58 percent vs. 25 percent for patients receiving dacarbazine.

mOS was estimated at 11.0 months in patients receiving binimetinib vs. 10.1 months for patients treated with dacarbazine. Binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS-mutant melanoma patients. Full results were presented at the American Society of Clinical Oncology Annual Meeting.