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.
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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).
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By GlobalDataOutcomes 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.
