A triple therapy combination of the drug could offer a “potentially practice-changing treatment option”, according to new late-stage data.
Pfizer’s oral small molecule kinase inhibitor Braftovi (encorafenib) significantly improved progression-free survival in metastatic colorectal cancer as part of a triple-therapy combination, new Phase III topline results show.
The pivotal BREAKWATER trial evaluated Braftovi in combination with Erbitux (cetuximab) and Folfiri (fluorouracil, leucovorin and irinotecan) in those with a BRAF V600E mutation.
Notably, key secondary endpoint outcomes from Cohort 3 found the regimen enabled a statistically significant improvement in progression-free survival compared to Folfiri with or without bevacizumab.
Additionally, meaningful prolonged improvement in overall survival was observed, and primary endpoint data showed positive outcomes for objective response rate.
The combination of significant responses and now improvement in progression‑free survival underscores the potential of Braftovi as a potentially practice-changing treatment option [in metastatic colorectal cancer]"
Jeff Legos, Chief Oncology Officer at Pfizer, said: “These results build on the positive objective response rate data we recently shared, providing further evidence of the meaningful benefit this Braftovi-based targeted approach may offer patients with BRAF V600E-mutant metastatic colorectal cancer.
“The combination of significant responses and now improvement in progression‑free survival underscores the potential of Braftovi as a potentially practice-changing treatment option for patients and families facing this challenging diagnosis.”
Pfizer plans to submit the findings from this cohort for a US approval in this indication, as well as presenting them at an upcoming medical meeting.
Braftovi alongside cetuximab and mFOLFOX6 gained accelerated FDA approval in December 2024 for patients with BRAF V600E-mutant mCRC.
Pfizer has rights to Braftovi in various countries including the US and Middle East, and companies with commercialisation rights to the medicine are Ono Pharmaceutical, Medison and Pierre Fabre Laboratories.
A $5 billion licensing deal made by AbbVie last month saw the firm gain access to RemeGen’s biologic RC148, currently in Phase II development for oncology indications including colorectal cancer.
