Pfizer's Conditionally Approved Braftovi Combo Therapy Regime Shows Improved Response In Colorectal Cancer Patients

On Saturday, Pfizer Inc. PFE revealed results from the Phase 3 BREAKWATER trial evaluating 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.

At the time of this analysis, the Braftovi combination regimen demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) compared to patients receiving chemotherapy with or without bevacizumab (60.9% vs. 40.0%).

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The results were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine.

The estimated median duration of response was 13.9 months with Braftovi plus cetuximab and mFOLFOX6 and 11.1 months with chemotherapy with or without bevacizumab.

Of patients on Braftovi plus cetuximab and mFOLFOX6, 22.4% (n=15) had a response lasting 12 months or longer, compared to 11.4% (n=5) with chemotherapy with or without bevacizumab.

The median time to response was 7.1 weeks with Braftovi plus cetuximab and mFOLFOX6 and 7.3 weeks with chemotherapy with or without bevacizumab.

Overall survival (OS) data were immature during this analysis but demonstrated a trend favoring Braftovi plus cetuximab and mFOLFOX6 compared to patients receiving chemotherapy with or without bevacizumab.

Median overall survival with Braftovi plus cetuximab with chemotherapy was not estimable, and 14.6 months with chemotherapy with or without bevacizumab.

The BREAKWATER trial is ongoing for OS and progression-free survival (PFS), with PFS results expected in 2025.

The safety profile of Braftovi in combination with cetuximab and mFOLFOX6 in the BREAKWATER trial was consistent with the known safety profile of each respective agent. No new safety signals were identified.

In December 2024, the FDA granted accelerated approval to Braftovi in combination with cetuximab and mFOLFOX6 for BRAF V600E-mutant mCRC.

Price Action: PFE stock is up 2.76% at $26.81 at the last check on Monday.

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