Zinger Key Points
- Pfizer's Phase 3 BREAKWATER trial showed Braftovi combo significantly improved PFS and OS in colorectal cancer with BRAF V600E mutation.
- The regimen demonstrated a 60.9% confirmed ORR, outperforming chemotherapy (40.0%), with no new safety concerns identified.
- Don’t miss this list of 3 high-yield stocks—including one delivering over 10%—built for income in today’s chaotic market.
On Monday, Pfizer Inc PFE revealed topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for 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, compared to patients receiving chemotherapy with or without bevacizumab.
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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 FDA granted accelerated approval to the Braftovi combination regimen in December 2024 for treatment-naïve patients with BRAF V600E-mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR), the study’s other dual primary endpoint.
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 Breakwater Trial
Last week, Pfizer 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%).
Price Action: PFE stock is down 0.87% at $26.29 at last check Monday.
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