First-Line Encorafenib and Cetuximab in BRAF V600E–Mutant Colon Cancer

Adding encorafenib and cetuximab to first-line chemotherapy significantly improves response rates and duration of response, making it the new standard of care.

In December 2024, the U.S. FDA granted accelerated approval for the combination of encorafenib and cetuximab (EC) with mFOLFOX6 (oxaliplatin, leucovorin, and 5-FU) for first-line treatment of BRAF-mutant colorectal cancer, based on the results of the industry-sponsored, phase 3 BREAKWATER trial. Now, investigators have published results of this trial, which featured dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS).

A total of 479 patients with previously untreated metastatic colorectal cancer with a BRAF V600E mutation were randomized to receive either EC with mFOLFOX6 or standard-of-care chemotherapy. Eighty percent had primary colon cancer, and 61% had right-sided tumors; 52% had prior complete or…

Reviewing Author

David H. Ilson, MD, PhD

Disclosures

Consultant/Advisory BoardAstraZeneca; Merck; Taiho; Astellas; Bristol Myers Squibb; Regeneron; Oncolys; Amgen; Daiichi Sankyo

David H. Ilson, MD, PhD

Disclosures

Consultant/Advisory BoardAstraZeneca; Merck; Taiho; Astellas; Bristol Myers Squibb; Regeneron; Oncolys; Amgen; Daiichi Sankyo

First-Line Encorafenib and Cetuximab in BRAF V600E–Mutant Colon Cancer

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Reviewing Author