Pfizer ‘s Braftovi regimen improves survival in colorectal cancer

Pfizer (PFE) announced positive topline progression-free survival, or PFS, results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi – encorafenib – in combination with cetuximab – marketed as Erbitux – and Folfiri in patients with previously untreated metastatic colorectal cancer, or mCRC, with a BRAF V600E mutation. The Braftovi regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint vs. treatment with Folfiri with or without bevacizumab. Overall survival, a descriptive secondary endpoint, also showed clinically meaningful prolonged improvement with the Braftovi regimen. At the time of the PFS analysis, the safety profile of Braftovi in combination with cetuximab and Folfiri was consistent with the known profile of each regimen component and no new safety signals were identified. Braftovi in combination with cetuximab and Folfiri is an investigational regimen and is not currently approved. Braftovi in combination with cetuximab and mFOLFOX6 received accelerated approval by the FDA in December 2024 for patients with BRAF V600E-mutant mCRC. Continued approval for this indication is contingent upon verification of clinical benefit.