ONO PHARMACEUTICAL : Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial (31.9KB)

February 7, 2018

Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial

Boulder, Colo., and Castres, France (February 6, 2018) - Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre announced results of the planned analysis of overall survival (OS) from the pivotal Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma. Treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001]. Median OS was 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.

The combination of encorafenib and binimetinib was generally well-tolerated. Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%). The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available BRAF+MEK-inhibitor treatments for patients receiving the combination of encorafenib and binimetinib included: rash (23%), pyrexia (18%), retinal pigment epithelial detachment (13%) and photosensitivity (5%).

Ono Pharmaceutical Co., Ltd. ("ONO") entered into the license agreement with Array BioPharma Inc. regarding binimetinib, a MEK inhibitor and encorafenib, a BRAF inhibitor in May 2017 and received rights to develop and commercialize both products in Japan and South Korea. Binimetinib and encorafenib are currently in two global Phase 3 clinical trials for the treatment of patients with BRAF-mutant melanoma (COLUMBUS study) and BRAF-mutant colorectal cancer (BEACON CRC study) as a combination therapy.

Please clickhere for the press release distributed by Array BioPharma Inc.

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