Pfizer's Conditionally Approved Braftovi Combo Therapy Regime Shows Improved Response In Colorectal Cancer Patients

Core Insights - Pfizer Inc. announced results from the Phase 3 BREAKWATER trial for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation [1][6] Efficacy Results - The Braftovi combination regimen showed a significant improvement in confirmed objective response rate (ORR) at 60.9% compared to 40.0% for chemotherapy with or without bevacizumab [2] - The estimated median duration of response was 13.9 months for the Braftovi combination versus 11.1 months for chemotherapy [3] - Among patients receiving Braftovi plus cetuximab and mFOLFOX6, 22.4% had a response lasting 12 months or longer, compared to 11.4% with chemotherapy [4] - The median time to response was 7.1 weeks for the Braftovi combination and 7.3 weeks for chemotherapy [4] Overall Survival Data - Overall survival (OS) data were immature but indicated a trend favoring the Braftovi combination over chemotherapy [5] - Median overall survival was not estimable for the Braftovi combination, while it was 14.6 months for chemotherapy [5] - The BREAKWATER trial is ongoing, with progression-free survival (PFS) results expected in 2025 [5] Safety Profile - The safety profile of Braftovi in combination with cetuximab and mFOLFOX6 was consistent with known safety profiles, with no new safety signals identified [6] - The FDA granted accelerated approval for Braftovi in combination with cetuximab and mFOLFOX6 for BRAF V600E-mutant mCRC in December 2024 [6] Market Reaction - Following the announcement, Pfizer's stock increased by 2.76% to $26.81 [6]