BriaCell Reports “Late-Breaker” Phase 3 Data at AACR 2025: Positive Tolerability Profile and Potential Response Biomarkers Identified

Core Viewpoint - BriaCell Therapeutics Corp. is presenting clinical data from its pivotal Phase 3 study of Bria-IMT™ for metastatic breast cancer, emphasizing the role of specific biomarkers in predicting patient responses to treatment [1][5]. Group 1: Clinical Data and Biomarkers - The Phase 3 study (BRIA-ABC) supports the use of biomarkers to predict clinical responses, potentially improving patient outcomes such as response rates and survival benefits [2][7]. - Early Phase 3 biomarker data indicates that positive delayed-type hypersensitivity (DTH) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) are linked to longer progression-free survival (PFS) [7][8]. - Kaplan Meier analysis of early clinical data (n=62) shows a median PFS of 3.67 months across all study arms [6]. Group 2: Treatment Efficacy and Safety - Positive DTH is associated with better PFS (4.5 months vs 2.5 months, p = 0.001), while specific NLR values correlate with lower median PFS [8]. - The Bria-IMT regimen has demonstrated a favorable safety profile, with no treatment discontinuations related to Bria-IMT, indicating excellent tolerability [9]. Group 3: Study Design and Future Prospects - The multicenter randomized open-label study compares the Bria-IMT regimen combined with a checkpoint inhibitor against physician's choice in advanced metastatic breast cancer patients [10]. - Interim data will be analyzed upon reaching 144 patient events, with positive results potentially leading to full approval and marketing authorization for Bria-IMT [11].