- Over 75 patients enrolled in BriaCell's pivotal Phase 3 study for metastatic breast cancer.
- Study spans 54 clinical sites across 15 U.S. states, with the FDA Fast Track designation granted.
- Potential for top-line data release in the first half of 2026, pending enrollment completion by late 2025 or early 2026.
BriaCell Therapeutics (BCTX, Financial), a clinical-stage biotechnology company, is witnessing accelerated enrollment in its Phase 3 clinical study evaluating Bria-IMT combined with an immune checkpoint inhibitor for advanced metastatic breast cancer. The study has successfully enrolled over 75 patients at 54 clinical sites spread across 15 states. The objective is to compare the overall survival of patients treated with Bria-IMT against those receiving treatment as per the physician's choice.
With plans to complete patient enrollment by late 2025 or early 2026, the company anticipates releasing top-line data in the first half of 2026. For interim analysis, the study requires 144 patient events (deaths), offering the first insights into comparative efficacy. The Bria-IMT regimen has earned the FDA Fast Track designation, reflecting its potential to address the unmet needs in metastatic breast cancer treatment.
Dr. William V. Williams, BriaCell’s President and CEO, expressed satisfaction with the pace of enrollment and the clinical investigator's interest, emphasizing the novel approach their therapy offers. Positive outcomes from the Phase 3 trial could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer treatment.
