Pfizer reported that the BRAFTOVI® (encorafenib) regimen combined with cetuximab and the FOLFIRI chemotherapy backbone achieved an objective response rate of 64.4% in Cohort 3 of the pivotal BREAKWATER trial, compared with 39.2% for standard‑of‑care FOLFIRI with or without bevacizumab. The 25‑percentage‑point lift translates into a clinically meaningful benefit for patients with the BRAF V600E mutation, a biomarker present in roughly 8‑12 % of metastatic colorectal cancer cases.
The improved response rate is significant because the BRAF V600E subset historically has limited options and poorer outcomes. A 64.4% ORR suggests that the triple‑combination could become a new standard of care for this hard‑to‑treat population, potentially expanding the market for targeted therapies in colorectal cancer.
Pfizer’s success builds on its recent acquisition of Seagen, completed in December 2023 for about $43 billion. The Seagen antibody‑drug conjugate platform strengthens Pfizer’s oncology pipeline and supports the company’s goal of eight blockbuster cancer drugs by 2030. The BRAFTOVI data reinforce Pfizer’s strategy to combine targeted inhibitors with proven antibody and chemotherapy backbones to create differentiated, high‑impact treatments.
Dr. Scott Kopetz, co‑principal investigator of the BREAKWATER trial, said the results “represent a great advance for patients with BRAF V600E‑mutant metastatic colorectal cancer. We’ve seen this approach significantly increase the response compared with FOLFIRI with or without bevacizumab, and these responses were rapid and durable.”
The findings were presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium and are expected to inform regulatory submissions and commercial plans for the BRAFTOVI combination. The data underscore Pfizer’s growing leadership in precision oncology and its ability to translate clinical success into a robust, diversified portfolio.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.