Pfizer’s Braftovi (encorafenib) combination therapy was shown to reduce the risk of death by nearly half compared to standard of care (SOC) for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutation.
The company announced the survival benefit in an abstract at the American Society of Clinical Oncology (ASCO) 2025 conference being held in Chicago, Illinois, between 30 May and 3 June.
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The results will be presented on the first day of the conference by Dr Elena Élez, co-principal investigator of the BREAKWATER trial, including primary progression-free survival (PFS) data and updated analysis of overall survival (OS).
The presentation includes new data from Pfizer’s Phase III trial (NCT04607421) of Braftovi in combination with Eli Lilly’s Erbitix (cetuximab) and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) in mCRC patients with BRAF V600E mutation.
In the study, the regimen elicited a 47% decreased risk of disease progression, with median PFS for treated patients at 12.8 months versus 7.1 months with SOC.
An updated analysis of the trial’s key secondary endpoint also shows the regimen led to a median OS of 30.3 months compared to 15.1 months with SOC, equating to a 51% reduction in risk of death for patients.
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By GlobalDataAs per a 30 May press release, Élez said: “The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant mCRC in the first-line setting.”
The combination was previously approved by the US Food and Drug Administration (FDA) for adult mCRC patients with CRAF V600E mutation following prior therapy in April 2020. The regimen has since gained accelerated approval as a first-line treatment in December 2024, based on interim overall response rate (ORR) data from the BREAKWATER study, with the full approval contingent on continued demonstration of efficacy.
Braftovi is a small-molecule inhibitor of BRAF, a protein involved in tumour cell growth, while Erbitux is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR). GlobalData projects the drugs to generate total annual sales of $1.14bn and $1.98bn by 2031, respectively.
GlobalData is the parent company of Clinical Trials Arena.
Pfizer’s hopes to entrench Braftovi as part of the SOC for mCRC were expressed by the company’s chief oncology development officer, Dr Joanna Bendell.
Colorectal cancer is the third most common type of cancer globally, and BRAF V600E mutations occur in between 8% and 12% of patients. Presently, this subpopulation of patients exhibits a risk of mortality double that of patients with no known BRAF mutation.
