Array BioPharma updates results from BEACON Phase 3 trial
Array BioPharma and Pierre Fabre 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 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 at the time of analysis was 8 months. The confirmed overall response rate in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses. Further, the ORR was 62% in the 16 patients 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. In the safety lead-in, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to adverse events with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue, urinary tract infection, increased aspartate aminotransferase and increased blood creatine kinase. All patients with elevated baseline levels of the tumor markers CEA and CA19-9 had a reduction from baseline, with similar and substantial reductions across both markers in patients with objective responses and those with stable disease. The enrollment in the randomized portion of the BEACON CRC trial is ongoing.