CHICAGO -- Adding encorafenib (Braftovi) and cetuximab (Erbitux) to FOLFIRI chemotherapy significantly improved progression-free survival (PFS) as first-line treatment of BRAF V600E-mutated metastatic colorectal cancer, according to secondary analysis of a randomized trial.
Results from cohort 3 of the BREAKWATER trial showed that adding the two targeted therapies to FOLFIRI (leucovorin, fluorouracil, and irinotecan) chemotherapy nearly doubled median PFS to 15.2 months compared with 8.3 months in the control group of patients who received FOLFIRI with or without bevacizumab (Avastin).
That difference represented a clinically meaningful 56% reduction in risk of progression or death (HR 0.44, 95% CI 0.27-0.79, P=0.0002), reported Scott Kopetz, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, at the annual meeting of the American Society of Clinical Oncology (ASCO).
At a median follow-up of about 21 months in both arms, overall survival (OS) was longer in the encorafenib/cetuximab arm, with median OS not reached versus 20.3 months in the control arm (HR 0.56, 95% CI 0.34-0.94).
"The cohort 3 data support the use of FOLFIRI as an option with [encorafenib/cetuximab] as a new standard of care for this BRAF V600E-mutant metastatic colorectal cancer population, and highlight the importance of prompt biomarker testing to really understand which patients have BRAF V600E mutations prior to starting first-line treatment," Kopetz said. "And this really allows improvement in personalized care."
