=Array Biopharma (ARRY) : results from the Phase 3 BEACON CRC study

Array Biopharma announces results from the Phase 3 BEACON CRC study evaluating binimetinib, encorafenib, and Erbitux in patients w/ RAF-mutant colorectal cancer whose disease has progressed after one or two prior regimens in the metastatic setting at ESMO 2017 

As of August 9, 2017, 30 patients were treated in the safety lead-in and received the triplet combination of binimetinib, encorafenib and cetuximab (BINI 45 mg twice daily, ENCO 300 mg daily and CETUX per label).

• Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high (MSI-H) (resulting from defective DNA mismatch repair) was detected in only one patient.
• The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study.
• In addition, promising initial clinical activity was observed, with a confirmed overall response rate (ORR) of 41%, including a complete response, in patients with the BRAFV600E mutation, a group of patients with historically poor outcomes. The observed ORR was 59% in the 17 patients with the BRAFV600E mutation with only one prior therapy.
• Out of 28 patients with both a BRAFV600E mutation and a post-baseline assessment, 27 showed tumor regression.
• Three patients discontinued treatment due to AEs with only one considered related to treatment.
• Co continues to enroll the randomized portion of the BEACON CRC study, assessing the efficacy of encorafenib in combination with cetuximab with or without binimetinib compared to cetuximab and irinotecan-based therapy.