Latest news with #mFOLFOX6
Yahoo
27-01-2025
- Business
- Yahoo
Pfizer's Conditionally Approved Braftovi Combo Therapy Regime Shows Improved Response In Colorectal Cancer Patients
On Saturday, Pfizer Inc. (NYSE:PFE) revealed results from the Phase 3 BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the Braftovi combination regimen demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) compared to patients receiving chemotherapy with or without bevacizumab (60.9% vs. 40.0%). Also Read: The results were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine. The estimated median duration of response was 13.9 months with Braftovi plus cetuximab and mFOLFOX6 and 11.1 months with chemotherapy with or without bevacizumab. Of patients on Braftovi plus cetuximab and mFOLFOX6, 22.4% (n=15) had a response lasting 12 months or longer, compared to 11.4% (n=5) with chemotherapy with or without bevacizumab. The median time to response was 7.1 weeks with Braftovi plus cetuximab and mFOLFOX6 and 7.3 weeks with chemotherapy with or without bevacizumab. Overall survival (OS) data were immature during this analysis but demonstrated a trend favoring Braftovi plus cetuximab and mFOLFOX6 compared to patients receiving chemotherapy with or without bevacizumab. Median overall survival with Braftovi plus cetuximab with chemotherapy was not estimable, and 14.6 months with chemotherapy with or without bevacizumab. The BREAKWATER trial is ongoing for OS and progression-free survival (PFS), with PFS results expected in 2025. The safety profile of Braftovi in combination with cetuximab and mFOLFOX6 in the BREAKWATER trial was consistent with the known safety profile of each respective agent. No new safety signals were identified. In December 2024, the FDA granted accelerated approval to Braftovi in combination with cetuximab and mFOLFOX6 for BRAF V600E-mutant mCRC. Price Action: PFE stock is up 2.76% at $26.81 at the last check on Monday. Read Next:Image via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? PFIZER (PFE): Free Stock Analysis Report This article Pfizer's Conditionally Approved Braftovi Combo Therapy Regime Shows Improved Response In Colorectal Cancer Patients originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
27-01-2025
- Business
- Yahoo
Pfizer reports positive outcomes from trial of mCRC combination therapy
Pfizer has reported positive outcomes from the Phase III BREAKWATER trial of BRAFTOVI plus cetuximab and mFOLFOX6 for treating metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. The study evaluated the combination against standard chemotherapy, with or without bevacizumab. During the period of analysis, the combination showed a clinically meaningful and statistically significant improvement in confirmed objective response rate as per blinded independent central review. Subjects treated with the combination regimen had a median time to respond of 7.1 weeks, with 22.4% experiencing a response lasting a minimum of one year. In contrast, only 11.4% of subjects on standard chemotherapy achieved a similar duration of response. Although overall survival (OS) data was not mature, there was a 'promising' trend favouring the combo regimen. The trial is underway for OS and progression-free survival (PFS). Outcomes of PFS are anticipated this year. The BREAKWATER trial's safety profile for the combination was consistent with expectations, showing no new safety signals. Serious treatment-emergent adverse events were slightly higher in the BRAFTOVI group than in the control group. Pfizer chief oncology officer Roger Dansey said: 'These results of this first analysis were the basis for the first approval of a targeted therapy regimen for use in the first-line setting for patients with metastatic colorectal cancer with a BRAF V600E mutation. 'We are highly encouraged by these response results, which are indicative of the clinically meaningful benefit of BRAFTOVI in reducing tumour size or having no detectable cancer, along with the promising interim analysis of overall survival.' The US Food and Drug Administration granted accelerated approval to the combination regimen last month, under Project FrontRunner. Discussions with other regulatory authorities are ongoing to support potential future licence applications for the regimen. Earlier this month, the company's CREST trial assessing sasanlimab with Bacillus Calmette-Guérin (BCG), as induction treatment with or without maintenance in individuals with BCG-naive, high-risk non-muscle invasive bladder cancer, met its primary endpoint. "Pfizer reports positive outcomes from trial of mCRC combination therapy" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
