ONO PHARMACEUTICAL : Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial (31.7KB)

January 22, 2018

Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial

BOULDER, Colo. and CASTRES, France (Jan. 20, 2018) - Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant metastatic colorectal cancer (CRC) whose disease has progressed after one or two prior regimens. The data were presented at the ASCO 2018 Gastrointestinal Cancers Symposium in San Francisco, California.

In patients with the BRAFV600E mutation, the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR)* in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy. These data represent substantial improvements compared to several separate historical published standard of care benchmarks for this population.

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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