Pfizer’s BRAFTOVI Regimen Nearly Doubles Median Progression-Free Survival in Metastatic Colorectal Cancer
Cohort 3 analysis from the Phase 3 BREAKWATER study showed a 56% reduction in the risk of disease progression or death compared to traditional chemotherapy regimen
Overall survival benefit was also observed, with a 44% reduction in the risk of death
BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy is the only approved targeted regimen for BRAF V600E-mutant metastatic colorectal cancer
Pfizer Inc. (NYSE: PFE) today announced detailed progression-free and overall survival results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These results will be presented today in a late-breaking oral presentation (Abstract LBA3503) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Annals of Oncology.
