On Saturday, Pfizer Inc. (NYSE:PFE) shared data from Cohort 3 of the BREAKWATER trial.
The Phase 3 BREAKWATER trial evaluated Braftovi (encorafenib) with cetuximab, alone or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
Trial Data
At the time of this analysis, the Braftovi combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001).
A confirmed ORR in cancer trials is the percentage of patients whose tumors shrink, and that response is verified by a follow-up scan, typically at least four weeks later.
The data were presented at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.
The estimated median duration of response was not estimable with Braftovi plus cetuximab and FOLFIRI (or with FOLFIRI with or without bevacizumab).
Of patients on Braftovi plus cetuximab and FOLFIRI, 57.4% had a response lasting 6 months or longer, compared to 34.5% with FOLFIRI with or without Roche Holdings AG’s (OTC:RHHBY) Avastin (bevacizumab).
Overall survival (OS) data were analyzed descriptively. The BREAKWATER trial is ongoing with an estimated completion in 2027.
Braftovi Background
Braftovi in combination with cetuximab and mFOLFOX6 received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E-mutant mCRC. This approval was based on a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) in treatment-naïve patients, which was one of the study’s primary endpoints. Continued approval for this indication is contingent upon verification of clinical benefit.
In December 2025, Pfizer shared detailed results from the Phase 3 HER2CLIMB-05 trial of Tukysa (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction.
The trial included patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with Tukysa, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab.
PFE Price Action: Pfizer shares were down 0.26% at $25.41 at the time of publication on Monday, according to Benzinga Pro data.
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