BriaCell to Present Positive Clinical Biomarker Data of Phase 3 Study at ESMO 2025

Core Insights - BriaCell Therapeutics Corp. is presenting positive clinical biomarker data from its pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor in metastatic breast cancer 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 plus CPI, Physician's Choice, or Bria-IMT monotherapy [2] - As of the abstract submission, data from 68 evaluable patients, with a median of 6 prior lines of treatment (ranging from 2 to 13), has been collected [2] Clinical Efficacy - Significant improvement in progression-free survival (PFS) was observed in biomarker-positive subgroups who developed an immune response to Bria-IMT, with a p-value of 0.0002 [3][9] - Positive delayed-type hypersensitivity (DTH) was significantly associated with longer PFS in a blinded analysis of current Phase 3 patients [9] Tolerability Profile - Bria-IMT was well tolerated, with no treatment-related discontinuations due to adverse events (AEs) [3] - The most common AEs reported were fatigue (22.8%), anemia (22.8%), and nausea (21.5%) [3] Future Analysis - Interim data will be analyzed once 144 patient events (deaths) occur, focusing on overall survival (OS) as the primary endpoint [5] - Positive results could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5] Regulatory Status - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential significance in treating metastatic breast cancer [5]