Bartivi for colon cancer – pro
ENcorefanib, cetuximab and FOlfox were studies in the phase III Breakwater study.Results from the phase 3 BREAKWATER trial (NCT04607421) shared at the 2025 Gastrointestinal Cancer Symposium demonstrated that encorafenib (Braftovi), cetuximab (Erbitux), and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) elicited an increase in overall response rate (ORR), when compared with chemotherapy alone, in the treatment of patients with BRAF V600E-mutated metastatic colorectal cancer (mCRC).
In December 2024, the FDA granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of patients with mCRC harboring a BRAF V600E mutation, as detected by an FDA-approved test.
Kopetz S, Yoshino T, Van Cutsem E, et al. BREAKWATER: Analysis of first-line encorafenib + cetuximab + chemotherapy in BRAF V600E-mutant metastatic colorectal cancer. J Clin Oncol. 2025;43(supp 4):16. doi:10.1200/JCO.2025.43.4_suppl.16
Kopetz, S., Yoshino, T., Van Cutsem, E. et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med 31, 901–908 (2025).