Pfizer announced Phase 3 BREAKWATER trial results for BRAFTOVI (encorafenib) at the 2026 ASCO Annual Meeting. The study evaluated the drug combination in previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer.
The BRAFTOVI regimen nearly doubled median progression-free survival to 15.2 months. The comparator arm recorded a median progression-free survival of 8.3 months. This data represents a 56% reduction in the risk of disease progression or death. The regimen also demonstrated a 44% reduction in the overall risk of death.
The FDA approved the combination of BRAFTOVI, cetuximab, and chemotherapy in February 2026. This approval followed earlier positive response rate data from the same trial. These results reinforce the treatment as a standard of care for this patient population.