Pfizer Inc. (NYSE: PFE) reported results from a Phase 3 clinical trial showing its BRAFTOVI regimen significantly improved outcomes for patients with metastatic colorectal cancer containing a specific genetic mutation.

The Cohort 3 analysis from the BREAKWATER study demonstrated that BRAFTOVI combined with cetuximab and FOLFIRI chemotherapy nearly doubled median progression-free survival to 15.2 months compared to 8.3 months for standard treatment. The combination showed a 56% reduction in risk of disease progression or death.

The study also found a 44% reduction in risk of death for patients receiving the BRAFTOVI combination, with 72% of patients expected to be alive at 18 months compared to 54.5% receiving standard treatment. Median overall survival was not reached for the BRAFTOVI group versus 20.3 months for the comparator.

The trial enrolled patients with previously untreated metastatic colorectal cancer carrying the BRAF V600E mutation, which occurs in 8-12% of metastatic colorectal cancer cases and is associated with poor prognosis.

Common side effects in the BRAFTOVI group included nausea, diarrhea, vomiting, anemia, and fatigue. Grade 3 or higher adverse events occurred in 70.4% of BRAFTOVI patients versus 80.9% in the control group.

Based on these and previous trial results, the FDA granted full approval for BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy for BRAF V600E-mutant metastatic colorectal cancer in February 2026.

The results were presented at the American Society of Clinical Oncology Annual Meeting and published in Annals of Oncology.