BREAKWATER Phase 3 Trial: A New Standard for First-Line BRAF V600E-Mutant mCRC Treatment
The BREAKWATER phase 3 trial, published in Nature Medicine, has demonstrated that encorafenib plus cetuximab (EC) with mFOLFOX6 significantly improves objective response rates compared to standard chemotherapy in BRAF V600E-mutant metastatic colorectal cancer (mCRC). The study reports a confirmed objective response rate of 60.9% with EC+mFOLFOX6 compared to 40.0% with standard chemotherapy, with a median duration of response of 13.9 months versus 11.1 months. The interim analysis of overall survival shows a hazard ratio of 0.47, suggesting a clear survival benefit for EC+mFOLFOX6.









