Journal article

BREAKWATER: Randomized phase 3 study of encorafenib (enco) cetuximab (cetux) ± chemotherapy for first-line (1L) treatment (tx) of BRAF V600E-mutant (BRAFV600E) metastatic colorectal cancer (mCRC).

Scott Kopetz, Axel Grothey, Rona Yaeger, Fortunato Ciardiello, Jayesh Desai, Tae Won Kim, Tim Maughan, Eric Van Cutsem, Harpreet Singh Wasan, Takayuki Yoshino, Michelle L Edwards, Adele Golden, Ashwin Gollerkeri, Josep Tabernero

Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2021


TPS3619 Background: Approximately 10% of patients (pts) with mCRC have BRAF mutations (mostly V600E). 1L tx options for BRAFV600E mCRC are limited to cytotoxic chemotherapy ± anti-VEGF or anti-EGFR, or immune checkpoint inhibitors in pts with MSI-H tumors. In Europe, Japan, and USA, the combination of BRAF inhibitor enco + EGFR inhibitor cetux is approved for tx of BRAFV600E mCRC after prior therapy. In BEACON CRC, enco + cetux resulted in a median overall survival (OS) of 9.3 months (95% confidence interval [CI]: 8.0–11.3) and an objective response rate (ORR) of 19.5% (95% CI: 14.5%–25.4%) in previously treated pts with BRAFV600E mCRC (median follow-up: 12.8 months); 57.4% of pts had grade..

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