Pfizer today reported positive results from Cohort 3 of the pivotal BREAKWATER trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab and FOLFIRI in 123 patients with previously untreated metastatic colorectal cancer harboring a BRAF V600E mutation. At a median follow-up of 12.8 months, the confirmed overall response rate was 58%, including 5 complete responses and 67 partial responses. The disease control rate reached 85%, with a median duration of response of 9.2 months. Median progression-free survival was 8.4 months, representing a 3.6-month improvement over historical controls treated with FOLFIRI and cetuximab alone. Treatment-emergent adverse events were consistent with known profiles of the individual agents, with grade 3 or higher neutropenia in 22% of patients and grade 3 diarrhea in 8%. These data support regulatory submissions planned in the second half of 2026 and position the BRAFTOVI triple regimen as a potential new standard of care for this high-risk patient population.