BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025

Executive Summary

• BriaCell presented encouraging interim biomarker data from its pivotal Phase 3 trial of Bria‑IMT™ plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer at the ESMO 2025 Congress.
• Neutrophil‑to‑Lymphocyte Ratio (NLR) continues to correlate with progression‑free survival (PFS): patients with NLR 0.7–2.3 showed a median PFS of 4.5 months vs. 2.5 months for those outside this range (HR 0.5, p = 0.005).
• The Phase 3 study remains blinded for efficacy endpoints; safety is favorable with no treatment‑related discontinuations and only mild adverse events reported.

Key Details

• Study Design: Randomized 1:1:1 to Bria‑IMT + CPI, physician’s choice therapy, or Bria‑IMT monotherapy.
• Population: Interim pooled data on 113 patients; median of 6 prior lines of therapy (range 2–13). All 113 evaluated for safety and PFS.
• Biomarker Insight: NLR identified as a potential predictive biomarker; HR 0.5 (95 % CI 0.3‑0.8) for PFS advantage in the favorable NLR subgroup.
• Efficacy Data: PFS comparison between Bria‑IMT + CPI and physician’s choice remains blinded; overall survival interim analysis will commence after 144 deaths.
• Safety Profile: No treatment‑related discontinuations; most common adverse events are fatigue, anemia, and nausea (all mild).
• Regulatory Status: Bria‑IMT combination regimen has FDA Fast Track designation. Positive Phase 2 results previously reported in a similar MBC cohort.
• Future Milestones: Interim analysis of overall survival pending 144 death events; positive outcomes could lead to full approval and marketing authorization for Bria‑IMT in metastatic breast cancer.
• Presentation Details: Poster #3928 titled “Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria‑IMT Cell Therapy in Late Stage MBC (BRIA‑ABC)” presented at ESMO 2025, Berlin, Germany (Oct 17‑21).
• Reference: ClinicalTrials.gov NCT06072612; poster available at https://briacell.com/scientific‑publications/.

Notable Quotes

“We are encouraged by the early constructive clinical biomarker data which could allow us to predict clinical and survival outcomes in our patients and would help guide treatment decisions for metastatic breast cancer patients with limited options,” – Dr. William V. Williams, President & CEO, BriaCell Therapeutics Corp.