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BriaCell Therapeutics (NASDAQ: BCTX) has reported impressive survival data from its Phase 2 clinical study of Bria-IMT in metastatic breast cancer patients. The study showed that 52% of the most recent 25-patient cohort survived beyond one year, surpassing current standard of care expectations. Notably, 11 patients remain alive, with two remarkable cases reaching 38.3 and 30.3 months of survival.
The study included heavily pre-treated patients who had previously failed multiple therapies, including checkpoint inhibitors and antibody-drug conjugates. The median number of prior treatments was 6, and importantly, no treatment discontinuations related to Bria-IMT have been reported, suggesting a well-tolerated profile.
BriaCell Therapeutics (NASDAQ: BCTX) has expanded its pivotal Phase 3 clinical trial for advanced metastatic breast cancer treatment by adding two major cancer centers: Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven, contributing 30 additional satellite locations. The study now encompasses 58 active clinical sites across 15 states.
The trial evaluates BriaCell's lead candidate Bria-IMT™ plus immune checkpoint inhibitor versus physician's choice. Patient enrollment is expected to complete by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint will analyze overall survival after 144 patient events, with positive results potentially leading to full approval and marketing authorization.
BriaCell Therapeutics (NASDAQ: BCTX) has received a positive safety review recommendation from the independent Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. This marks the third consecutive positive recommendation from the DSMB, which found no safety concerns and recommended the study continue without modifications.
The study is being conducted under FDA Fast Track Designation, highlighting the significant unmet medical need in metastatic breast cancer patients. The DSMB reviews occur quarterly as per study protocol, and this latest recommendation further validates the favorable safety profile of BriaCell's immunotherapy treatment.
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