Pierre Fabre and Array BioPharma have unveiled data from a late-stage trial showing a significant improvement in one-year survival in colorectal cancer patients taking encorafenib, binimetinib and cetuximab versus the standard of care.
The Phase III BEACON CRC trial is evaluating the triplet combination of these drugs - a BRAF inhibitor, MEK inhibitor and anti-EGFR antibody, respectively - in patients with BRAFV600E-mutant metastatic colorectal cancer (CRC).
The results showed a one-year survival rate of 62 percent, and an overall response rate (ORR) of 48 percent.
“The results of the BEACON CRC safety lead-in demonstrate substantial improvements in efficacy outcomes when compared to current approved standard of care benchmarks in patients with BRAF-mutant metastatic CRC,” said Axel Grothey, Division of Hematology/Oncology, Mayo Clinic.
“The median progression-free survival of eight months is a meaningful improvement compared to the benchmark of about two months, and the overall survival of 62 percent at 12 months is very promising given that with current approved standards of care, half of patients will succumb to their disease within four to six months.”
Also, the triple combination was generally well-tolerated with no unexpected toxicities, with the most common grade 3 or 4 adverse events seen in at least 10 percent of patients being fatigue (13 percent), anaemia (10 percent), increased blood creatine kinase (10 percent) and increased aspartate aminotransferase (10 percent).
US and EU regulators are currently reviewing the New Drug Applications (NDAs) to support use of the combination of encorafenib and binimetinib in patients with BRAFV600E or BRAFV600K-mutant, unresectable or metastatic melanoma.