Updated results from BEACON CRC trial of Braftovi + Mektovi + cetuximab for patients with BRAFV600E-mutant metastatic colorectal cancer.-Array Biopharma.
As presented at the ESMO 20th World Congress on Gastrointestinal Cancer in June 2018 , the results from the safety lead-in of the ongoing randomized Phase III BEACON CRC trial for Braftovi + Mektovi and cetuximab combination in patients with BRAFV600E-mutant metastatic colorectal cancer showed that, at the time of analysis, the overall survival (OS) data were fully mature through 12.6 months and that the median OS had not yet been reached.
One-year overall survival rate for this cohort was 62%. Median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. Confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%.
The triplet combination was generally well-tolerated wth no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%). The triplet combination of Braftovi, Mektovi and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer is investigational and not approved by the FDA .