Pfizer's BRAFTOVI Combo Nearly Doubles PFS In BRAF V600E Metastatic Colorectal Cancer (PFE)

Pfizer Inc. (PFE) said on May 31, 2026 that its BRAFTOVI combination regimen nearly doubled progression-free survival in patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer, marking a significant advancement in an aggressive tumor type with limited options. Interim Phase 3 BREAKWATER trial results showed the encorafenib-based combination reduced the risk of disease progression or death by approximately 48% compared to standard chemotherapy alone. Median progression-free survival reached 12.2 months for the BRAFTOVI arm versus 6.5 months for the control group. The regimen pairs BRAFTOVI with cetuximab and mFOLFOX chemotherapy. The data position Pfizer to pursue expanded global regulatory approvals for this rare molecular subtype, which accounts for about 10% of metastatic colorectal cancers. BRAFTOVI is already marketed in combination with cetuximab for previously treated BRAF V600E-mutant colorectal cancer and in certain melanomas. Detailed results will be presented at an upcoming medical meeting.