Array BioPharma Provides Update On Phase 3 Trials; NEMO Meets Primary Endpoint

(RTTNews) - Array BioPharma Inc. (ARRY) announced the company plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. In December 2015, Array reported top-line results from the ongoing Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival compared with dacarbazine treatment.

Array expects top-line results from Part 1 of the COLUMBUS trial in the first half of 2016 and projects a regulatory filing of binimetinib and encorafenib in 2016. In October 2015, Part 2 of COLUMBUS achieved its target patient enrollment.

The MILO Phase 3 study in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates enrollment to be complete in 2016 with the availability of top-line data, along with a projected regulatory filing, in 2017.

Based on the strength of the Phase 2 combination data with encorafenib in patients with BRAF-mutant colorectal cancer, Array plans to initiate a Phase 3 global registration trial in that patient population in 2016.

Array BioPharma reported that its second-quarter revenue increased $8.5 million primarily due to $27.3 million in reimbursement revenue from Novartis. Research and development expense increased $29.5 million compared to the second quarter of fiscal 2015 due to the categorization of binimetinib costs, as well as new spending on encorafenib. Net loss for the second quarter of fiscal 2016 was $24.2 million, or $0.17 per share, and was $8.6 million, or $0.06 per share, for the same quarter in fiscal 2015.