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2mo ago

Triplet Therapy Doubles Survival in BRAF V600E Metastatic Colorectal Cancer

Phase III data validate December’s accelerated FDA decision by confirming the encorafenib, cetuximab and mFOLFOX6 combination as a new standard of care for this aggressive molecularly defined disease.

Laurie Ritchie, 61, of St. Louis.

Overview

  • The Phase III BREAKWATER trial enrolled 637 untreated patients with BRAF V600E-mutated metastatic colorectal cancer and showed median overall survival of 30.3 months versus 15.1 months with standard chemotherapy.
  • The triplet regimen cut the risk of death by 51% and reduced the risk of disease progression or death by 47%, extending median progression-free survival to 12.8 months from 7.1 months.
  • Safety outcomes were consistent with known profiles of the agents, with serious adverse events largely reversible and managed through dose adjustments and supportive care.
  • The FDA granted accelerated approval for the combination in December 2024 based on promising response rates, and the new survival data now substantiate its broader use as first-line therapy.
  • These findings underscore the importance of routine molecular profiling to identify patients with BRAF V600E mutations who can benefit from targeted upfront treatment.