Pfizer announces results from Cohort 3 of BREAKWATER trial

Pfizer (PFE) announced results from Cohort 3, a separate randomized cohort of the BREAKWATER trial, evaluating BRAFTOVI in combination with cetuximab and FOLFIRI in patients with previously untreated metastatic colorectal cancer, mCRC, with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate, ORR, assessed by blinded independent central review, BICR, compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab. These data will be presented today in an oral presentation at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium and highlighted in the ASCO GI official press program. Cohort 3 analysis from the BREAKWATER study shows objective response rate of 64% with BRAFTOVI plus cetuximab and FOLFIRI compared to 39% with standard-of-care treatment FOLFIRI with or without bevacizumab.