BRAFTOVI plus FOLFIRI and ERBITUX boosts response rates in BRAF V600E mCRC trial
Pfizer reported positive Cohort 3 data from the BREAKWATER trial showing its BRAFTOVI regimen with cetuximab and FOLFIRI achieved superior response rates in previously untreated mCRC patients with BRAF V600E mutations. The findings could support regulatory submissions for the triplet combination as a new standard of care.
1. Pfizer Reports Enhanced Response Rates in BREAKWATER Trial
Pfizer today disclosed topline results from Cohort 3 of the pivotal BREAKWATER study, showing that the triplet regimen of BRAFTOVI® (encorafenib), ERBITUX® (cetuximab) and FOLFIRI (fluorouracil, leucovorin, irinotecan) achieved an objective response rate (ORR) of 58% in previously untreated patients with metastatic colorectal cancer harboring the BRAF V600E mutation. This represents an improvement of more than 25 percentage points compared with historical control data for doublet regimens in this population. Median progression-free survival was 8.3 months, exceeding the 5-month benchmark associated with standard chemotherapy plus cetuximab, and the safety profile was consistent with known class effects, with grade 3 or higher neutropenia in 19% of patients and diarrhea in 12%. Based on these data, Pfizer plans to discuss accelerated regulatory submissions with health authorities in the second half of 2026, positioning the regimen as a potential new standard of care in a subgroup with historically poor outcomes.