Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%

Pfizer Inc. PFE on Friday released data from Phase 3 BREAKWATER trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.

The study showed statistically significant and clinically meaningful survival results.

The data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.

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In a second interim analysis of overall survival (OS), a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab (Hazard Ratio [HR] 0.49).

Median OS was 30.3 months with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab.

In the primary analysis of progression-free survival (PFS), the BRAFTOVI combination regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab (HR 0.53) as assessed by blinded independent central review (BICR).

Median PFS was 12.8 months with the BRAFTOVI combination regimen compared to 7.1 months.

The updated objective response rate (ORR) by BICR confirmed the improvement previously observed with the BRAFTOVI combination regimen compared to patients receiving chemotherapy with or without bevacizumab.

The prior primary analysis also maintained the estimated median duration of response and median time to response.

The BRAFTOVI combination regimen received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, the study’s other dual primary endpoint.

Continued approval for this indication is contingent upon verification of clinical benefit.

The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025.

Price Action: PFE stock is up 0.51% at $23.57 at the last check on Friday.

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