Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer
Shots:
- Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243)
- Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR (1EP). ORR data was presented at ASCO GI 2025 & published in the Nature Medicine in Jan 2025, whereas full data will be featured at future meetings
- Latest results will be shared with the FDA to support full approval of the Braftovi regimen following its accelerated approval in Dec 2024. Data is under regulatory review globally
Ref: Pfizer | Image: Pfizer
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