Topline data on a combo including Pfizer’s kinase inhibitor Braftovi point to improved progression-free survival and pave the way for its full approval for the treatment of certain colorectal cancers, according to the company.
Pfizer on Monday released topline data from the Phase III BREAKWATER study, demonstrating that a combination regimen featuring Braftovi significantly improves survival in certain colorectal cancer patients.
The pharma did not provide specific data in its press release, only revealing that patients treated with the Braftovi combo saw a “statistically significant and clinically meaningful improvement” in progression-free survival (PFS), one of the two primary endpoints of BREAKWATER. Overall survival, a key secondary outcome, was also significantly and clinically better in the Braftovi arm.
In BREAKWATER, Pfizer combined Braftovi, an oral small molecule kinase inhibitor that targets the BRAF gene, with the EGFR blocker cetuximab and the chemotherapy regimen known as mFOLFOX-6. Comparators, meanwhile, were given chemotherapy with or without the VEGF inhibitor bevacizumab. To be eligible for enrollment, colorectal cancer patients had to be treatment-naive, have metastatic disease and harbor a V600E mutation in BRAF. More than 800 participants were ultimately enrolled into the study.
In January, Pfizer revealed in a presentation at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium that Braftovi aced its other primary endpoint of objective response rate (ORR). The Braftovi combo resulted in a 60.9% ORR versus 40% in control counterparts—a treatment difference that was statistically significant.
According to the company, these findings from BREAKWATER will help build its case to “potentially support full approval for Braftovi in combination with cetuximab and mFOLFOX6” in this indication.
Roger Dansey, Pfizer’s chief oncology officer, said that the pharma is “extremely pleased” with BREAKWATER’s results, noting that they point to Braftovi’s “potential to be practice-changing for this patient population.” Aside from taking these data to health authorities, the pharma also promised to present them at an upcoming medical congress.
Monday’s Braftovi readout continues Pfizer’s recent winning streak in cancer. Last month, the company reported that its subcutaneous PD-1 blocker sasanlimab, when given with Bacillus Calmette-Guérin immunotherapy, results in a significant and clinically meaningful improvement in event-free survival in certain patients with non-muscle invasive bladder cancer. The pharma at the time noted that it plans to file a regulatory submission for sasanlimab in this indication.
Meanwhile, in December 2024, Pfizer’s Ibrance notched a late-stage victory when it extended PFS by over 50% in patients with first-line HR+, HER2+ metastatic breast cancer. The CDK4/6 inhibitor was being tested as a first-line maintenance treatment in combination with anti-HER2 and endocrine therapy.
