BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025

Core Insights - BriaCell Therapeutics Corp. announces positive clinical biomarker data from its ongoing pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor for metastatic breast cancer, presented at the ESMO Congress 2025 [1][2] Study Details - The Phase 3 study involves randomizing patients in a 1:1:1 ratio to receive Bria-IMT + CPI, Treatment of Physician's Choice, or Bria-IMT monotherapy, with pooled data available from 113 patients who had a median of 6 prior treatment lines [3] - The study continues to evaluate safety and progression-free survival (PFS) among all patients, with no treatment-related discontinuations reported due to adverse events [5][11] Biomarker Findings - Neutrophil to Lymphocyte Ratio (NLR) is identified as a potential biomarker, showing significantly higher PFS in patients with NLR between 0.7 and 2.3 (4.5 months) compared to those with NLR < 0.7 or > 2.3 (2.5 months) [4] - Similar encouraging trends in biomarkers from the Phase 2 study are observed in the ongoing Phase 3 study [11] Future Prospects - Interim data analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint, with positive results potentially leading to full approval and marketing authorization for Bria-IMT in metastatic breast cancer [7]