articleNature MedicineJan 25, 2025HYBRID OA

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial

The University of Texas MD Anderson Cancer Center · National Cancer Center Hospital East · +18 more institutions

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Abstract

Encorafenib + cetuximab (EC) is approved for previously treated BRAF V600E-mutant metastatic colorectal cancer (mCRC) based on the BEACON phase 3 study. Historically, first-line treatment of BRAF V600E-mutant mCRC with chemotherapy regimens has had limited efficacy. The phase 3 BREAKWATER study investigated EC+mFOLFOX6 versus standard of care (SOC) in patients with previously untreated BRAF V600E mCRC. The dual primary endpoint of progression-free survival is event driven; data were not mature at data cutoff. BREAKWATER met the other dual primary endpoint of objective response rate, demonstrating significant and clinically relevant improvement in objective response rate (EC+mFOLFOX6: 60.9%; SOC: 40.0%; odds…

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Authors

15

Topics & keywords

Keywords
  • Medicine
  • Hazard ratio
  • Cetuximab
  • Clinical endpoint
  • Internal medicine
  • Oncology
  • Colorectal cancer
  • Confidence interval
UN Sustainable Development Goals
  • Clean water and sanitation
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