BriaCell Therapeutics Corp. announced positive Phase 2 clinical trial data for its Bria-IMT™ immunotherapy in metastatic breast cancer, demonstrating survival and clinical benefit outcomes meeting or exceeding those of FDA-approved therapies. The data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Notably, Bria-IMT™ showed these results in a patient population with more prior treatments than those in comparator studies, and no patients discontinued treatment due to Bria-IMT™ related side effects.
This news is vital because it suggests a potential new treatment option for metastatic breast cancer, a disease with significant unmet needs. The fact that Bria-IMT™ performed well in heavily pre-treated patients is particularly encouraging, as it addresses a patient population with limited effective options. If these results are confirmed in the ongoing Phase 3 trial, Bria-IMT™ could represent a significant advancement in the treatment landscape.
The Phase 2 study involved 54 patients and evaluated overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR). The Phase 3 regimen of Bria-IMT™ (without IFNγ) showed a median OS of 13.4 months and a CBR of 61%, comparing favorably to the 11.8 months OS and 40% CBR seen with sacituzumab govitecan in the ASCENT trial, and the 14.4 months OS and 34% CBR observed with the same drug in the TROPiCS-02 trial. Bria-IMT™ also achieved a 14% ORR, on par with or exceeding the control groups in both comparator trials. Data from a Phase 1/2 study of Bria-OTS™, another BriaCell immunotherapy, will also be presented at ASCO, including the case of one patient with confirmed resolution of a lung metastasis.
Positive Phase 3 results could lead to a Biologics License Application and potentially an accelerated approval pathway. This would represent a major milestone for BriaCell, validating its immunotherapy platform and potentially offering a new treatment option to patients with advanced breast cancer. Furthermore, positive results could attract further investment and partnerships, enabling further research and development of BriaCell’s immunotherapies for other cancer types.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
