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Braftovi Combo Improves Survival

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Published:4th Feb 2025
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Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase III  BREAKWATER study of Braftovi (encorafenib) in combination with cetuximab (Erbitux)) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation

The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints, as assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab. Further, the BRAFTOVI combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint in the trial.

The ORR results were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine in January 2025  At the time of the ORR analysis, the safety profile of Braftovi in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. No new safety signals were identified. Detailed results from this analysis will be submitted for presentation at an upcoming medical meeting. Pfizer will share these latest results with the FDA to potentially support full approval for Braftovi in combination with cetuximab and mFOLFOX6 in patients with mCRC with a BRAF V600E mutation. The BREAKWATER data are also being discussed with other regulatory authorities around the world to support potential additional license applications for the  Braftovi combination regimen in this indication.

BREAKWATER is a Phase III, randomized, active-controlled, open-label, multicenter trial of Braftovi with cetuximab, alone or in combination with mFOLFOX6 in participants with previously untreated BRAF V600E-mutant metastatic CRC. Patients were randomized to receive Braftovi 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), Braftovi 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (control-arm) (n=243). The dual primary endpoints are ORR, which was met at the time of analysis, and progression-free survival (PFS) as assessed by blinded independent central review (BICR). Overall survival is a key secondary endpoint.

“We are extremely pleased with the clinically meaningful progression-free survival and overall survival results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes,” said Dr. Roger Dansey,  Chief Oncology Officer, Pfizer. “The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation. We look forward to discussing these data with global health authorities to bring this treatment to more patients around the world, as soon as possible.”

See citation- Kopetz S., Yoshino T., Van Cutsem E. et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med  2025. https://doi.org/10.1038/s41591-024-03443-3

Condition: Colorectal Cancer/BRAF V600 E
Type: drug
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