The Investor
17 Feb 2026, 22:53
Pfizer Reports Positive BREAKWATER Data for BRAFTOVI in Metastatic Colorectal Cancer
Pfizer Inc. announced that Cohort 3 of the Phase 3 BREAKWATER trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BRAFTOVI® (encorafenib) combined with cetuximab (ERBITUX®) and FOLFIRI in previously untreated patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC).
The BRAFTOVI-based regimen improved PFS versus FOLFIRI with or without bevacizumab, with overall survival also showing clinically meaningful prolongation. The safety profile was consistent with known components of the regimen, and no new safety signals were identified.
Earlier results from the same cohort demonstrated positive objective response rate (ORR) data, presented at the 2026 ASCO GI Cancers Symposium. Detailed findings will be submitted to regulators to support potential approval of BRAFTOVI plus cetuximab and FOLFIRI in this first-line setting.
BRAFTOVI is already approved in combination with cetuximab and mFOLFOX6 under accelerated approval for treatment-naïve patients with BRAF V600E–mutant mCRC, based on confirmed response rates.
Colorectal cancer is the third most common cancer globally, and BRAF mutations occur in 8–12% of metastatic cases, typically associated with poor prognosis.
Source: Business Wire
Pfizer Inc. announced that Cohort 3 of the Phase 3 BREAKWATER trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BRAFTOVI® (encorafenib) combined with cetuximab (ERBITUX®) and FOLFIRI in previously untreated patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC).
The BRAFTOVI-based regimen improved PFS versus FOLFIRI with or without bevacizumab, with overall survival also showing clinically meaningful prolongation. The safety profile was consistent with known components of the regimen, and no new safety signals were identified.
Earlier results from the same cohort demonstrated positive objective response rate (ORR) data, presented at the 2026 ASCO GI Cancers Symposium. Detailed findings will be submitted to regulators to support potential approval of BRAFTOVI plus cetuximab and FOLFIRI in this first-line setting.
BRAFTOVI is already approved in combination with cetuximab and mFOLFOX6 under accelerated approval for treatment-naïve patients with BRAF V600E–mutant mCRC, based on confirmed response rates.
Colorectal cancer is the third most common cancer globally, and BRAF mutations occur in 8–12% of metastatic cases, typically associated with poor prognosis.
Source: Business Wire