Pfizer today reported that in Cohort 3 of the pivotal BREAKWATER study, previously untreated metastatic colorectal cancer patients harboring the BRAF V600E mutation achieved an overall response rate (ORR) of 57 percent when treated with the triplet regimen of BRAFTOVI® (encorafenib), cetuximab and FOLFIRI, compared to an ORR of 35 percent for the doublet without chemotherapy. The median duration of response for the triplet arm reached 9.8 months versus 5.4 months in the control group. Additionally, median progression-free survival improved from 4.1 months to 7.2 months, representing a 42 percent reduction in risk of disease progression or death. Adverse events were consistent with known profiles for each agent, with grade 3–4 neutropenia observed in 22 percent of triplet-treated patients and manageable through dose modifications. These robust data support regulatory submissions in the second half of 2026 and reinforce Pfizer’s position in targeted oncology, potentially driving durable revenue streams beyond its established immuno-oncology portfolio.