Positive Phase III results for Pfizer’s Braftovi combo

US pharma giant Pfizer (NYSE: PFE) on Saturday announced positive results from the Phase III BREAKWATER trial evaluating its Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.

Pfizer noted that, at the time of this analysis, the Braftovi combination regimen demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab (60.9% versus 40.0%, odds ratio =2.443, p=0.0008).

Pfizer acquired rights to Braftovi along with its $11.4 billion buy of Array BioPharma in 2019. The combination formulation won US Food and Drug Administration (FDA) approval for mCRC in December last year. The approval was among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease, Pfizer noted.