On Monday, Pfizer Inc PFE revealed topline outcomes from the progression-free survival (PFS) evaluation of the Part 3 BREAKWATER examine of Braftovi (encorafenib) together with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for metastatic colorectal most cancers (mCRC) harboring a BRAF V600E mutation.
The trial confirmed a statistically vital and clinically significant enchancment in PFS, considered one of its twin major endpoints, in comparison with sufferers receiving chemotherapy with or with out bevacizumab.
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Additional, the Braftovi mixture routine demonstrated a statistically vital and clinically significant enchancment in total survival (OS), a key secondary endpoint within the trial.
The FDA granted accelerated approval to the Braftovi mixture routine in December 2024 for treatment-naïve sufferers with BRAF V600E-mutant mCRC based mostly on a clinically significant and statistically vital enchancment in confirmed goal response price (ORR), the examine’s different twin major endpoint.
On the time of the ORR evaluation, the security profile of Braftovi, together with cetuximab and mFOLFOX6, continued to be in line with the identified security profile of every respective agent. No new security indicators had been recognized.
Detailed outcomes from this evaluation might be submitted for presentation at an upcoming medical assembly.
Pfizer Breakwater Trial
Final week, Pfizer revealed outcomes from the Part 3 BREAKWATER trial evaluating Braftovi (encorafenib) together with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in sufferers with metastatic colorectal most cancers (mCRC) with a BRAF V600E mutation.
On the time of this evaluation, the Braftovi mixture routine demonstrated a clinically significant and statistically vital enchancment in confirmed goal response price (ORR) in comparison with sufferers receiving chemotherapy with or with out bevacizumab (60.9% vs. 40.0%).
Worth Motion: PFE inventory is down 0.87% at $26.29 finally test Monday.
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