Pfizer announce statistically significant results from Phase 3 BREAKWATER trial

Pfizer (PFE) announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with metastatic colorectal cancer with a BRAF V600E mutation. These data will be presented today in an oral presentation at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and have been simultaneously published in the New England Journal of Medicine. In a second interim analysis of overall survival, OS, a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab. Median OS was 30.3 months with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab. In the primary analysis of progression-free survival, the BRAFTOVI combination regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab as assessed by blinded independent central review. Median PFS was 12.8 months with the BRAFTOVI combination regimen compared to 7.1 months.