Pfizer Reports Phase III Benefit for Braftovi Combination in mCRC

Pfizer announced positive results from cohort three of the Phase III BREAKWATER trial (NCT04607421) in previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Patients received Braftovi (encorafenib) plus Erbitux and FOLFIRI, compared with FOLFIRI with or without Avastin.

The triplet regimen improved progression-free survival, while overall survival showed clinically meaningful improvement as a secondary endpoint. The safety profile was consistent with known data and no new safety concerns emerged. Pfizer plans to present the findings at a medical meeting and discuss them with the U.S. Food and Drug Administration to support potential approval.

Another BREAKWATER cohort previously led to accelerated FDA approval of Braftovi with Erbitux and mFOLFOX6 in treatment-naïve BRAF V600E-mutant mCRC, demonstrating significant reductions in progression and mortality risk.

27-02-2026