A randomised study of encorafenib, cetuximab, and FOLFIRI versus FOLFIRI with or without bevacizumab in BRAF V600E-mutant colorectal cancer: BREAKWATER Cohort 3 - PubMed
4 hours ago
- #BRAF V600E-mutant colorectal cancer
- #randomized clinical trial
- #encorafenib-cetuximab-FOLFIRI
- The BREAKWATER Cohort 3 study compared EC+FOLFIRI (encorafenib + cetuximab + FOLFIRI) versus FOLFIRI with/without bevacizumab in previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
- EC+FOLFIRI showed statistically significant improvements: ORR was 64.4% vs. 39.2% (odds ratio 2.756, P=0.0011), meeting the primary endpoint.
- PFS was significantly longer with EC+FOLFIRI (15.2 months vs. 8.3 months, hazard ratio 0.44, P=0.0002), meeting the key secondary endpoint.
- A trend toward prolonged OS was observed with EC+FOLFIRI (hazard ratio 0.56 vs. 20.3 months in control).
- Safety profiles were manageable and consistent with known agents, with serious adverse event rates of 49.3% vs. 44.1% for EC+FOLFIRI vs. control.
- The data support EC+FOLFIRI as a new standard of care for BRAF V600E-mutant mCRC, enabling treatment personalization.