Global pharma giant Pfizer has reported promising new data from its ongoing trial -- showing breakthrough results in patients with aggressive colorectal cancer.
The Cohort 3 study of the pivotal BREAKWATER trial showed its BRAFTOVI (encorafenib) combination therapy delivers a significant response in patients with previously untreated metastatic colorectal cancer (mCRC) harboring the BRAF V600E mutation.
The trial tested BRAFTOVI alongside cetuximab (ERBITUX) and FOLFIRI chemotherapy against the standard-of-care FOLFIRI with or without bevacizumab. Results revealed a striking improvement in confirmed objective response rate (ORR): 64.4% for the BRAFTOVI combo versus 39.2% for standard treatment.
“These results represent a great advance for patients with BRAF V600E-mutant metastatic colorectal cancer. We’ve seen this approach significantly increase the response compared to FOLFIRI with or without bevacizumab, and these responses were rapid and durable,” said Scott Kopetz, co-principal investigator of BREAKWATER and Deputy Chair of Gastrointestinal Medical Oncology at MD Anderson Cancer Center.
“The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population.”
Among patients receiving the BRAFTOVI regimen, 57.4% had a response lasting six months or longer, compared to 34.5% with standard therapy. Median duration of response was not yet estimable. Early overall survival trends were encouraging, with a hazard ratio of 0.49, although the trial is ongoing, with completion expected in 2027.
“These data further strengthen the potential utility of BRAFTOVI for patients with BRAF V600E-mutant metastatic colorectal cancer. The significant improvement in response rates reflects the meaningful clinical benefit of this targeted combination therapy regimen for patients,” said Jeff Legos, Chief Oncology Officer, Pfizer.
“These results underscore the potential of BRAFTOVI as a standard of care for patients with this aggressive cancer and reflect our commitment to advancing precision medicine options that help tailor treatment based on patients’ needs.”
The safety profile of the combination was consistent with known effects of each agent. No new safety signals were reported. Common side effects (≥15%) included nausea, diarrhea, vomiting, alopecia, anemia, neutropenia, fatigue, rash, and weight loss. Only 8.5% of patients discontinued BRAFTOVI due to adverse reactions.
