BREAKWATER Phase III: results for encorafenib and cetuximab plus mFOLFOX6 in first-line <i>BRAF</i> V600E-mutant metastatic colorectal cancer.

ABSTRACT: The BREAKWATER Phase III study investigated encorafenib and cetuximab plus mFOLFOX6 versus chemotherapy with or without bevacizumab for the treatment of patients with previously untreated BRAF V600E - mutant metastatic colorectal cancer. The study showed significantly improved objective response rate by blinded independent central review, and significantly longer progression-free survival by blinded independent central review and overall survival in patients treated with first-line encorafenib and cetuximab plus mFOLFOX6 compared with chemotherapy with or without bevacizumab. The safety profiles were consistent with those known for each agent. These results led to the approval of encorafenib and cetuximab plus mFOLFOX6 for the treatment of BRAF V600E-mutant metastatic colorec

SUBMITTER: Kopetz S 

PROVIDER: S-EPMC12698039 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature