Pfizer’s Braftovi improves survival in Phase 3 colorectal cancer trial

Pfizer (PFE) announced positive topline results from the progression-free survival – PFS – analysis of the Phase 3 BREAKWATER study of Braftovi – encorafenib – in combination with cetuximab – marketed as Erbitux – and mFOLFOX6 in patients with metastatic colorectal cancer harboring a BRAF V600E mutation. The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints vs. patients receiving chemotherapy with or without bevacizumab. Further, the Braftovi combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival – OS -, a key secondary endpoint in the trial. The Braftovi combination regimen received accelerated approval by the FDA in December 2024 for treatment-naive patients with BRAF V600E-mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed objective response rate, the study’s other dual primary endpoint. The safety profile of Braftovi in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. Pfizer will share these latest results with the FDA to potentially support full approval for Braftovi in combination with cetuximab and mFOLFOX6 in patients with mCRC with a BRAF V600E mutation.