ASCO: Pfizer’s Braftovi combo regimen cuts risk of death

2 June 2025

US pharma giant Pfizer (NYSE: PFE) on Saturday announced statistically-significant and clinically-meaningful survival results from the Phase III BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.

These data were in an oral presentation (Abstract LBA3500) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the New England Journal of Medicine.

The data showed a surprisingly compelling overall survival (OS) benefit. TheBraftovi combination regimen received Food and Drug Administration accelerated approval as a first-line treatment for BRAF V600E-mutant mCRC in December 2024, and full approval based on the OS data is now expected.

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