BriaCell Therapeutics Corp. disclosed that its Phase 2 study of the Bria‑IMT cell therapy combined with the checkpoint inhibitor retifanlimab produced encouraging overall‑survival results in heavily pre‑treated metastatic breast cancer patients. The median overall survival (OS) was 15.6 months for patients treated after 2022 and 13.4 months overall across the 54‑patient cohort, with nine patients surviving longer than 18 months and some extending beyond 47 months.
The study highlighted two illustrative cases: a 66‑year‑old woman with triple‑positive disease who survived 27 months after enrollment, and a 44‑year‑old woman with HER2‑negative disease who remains in follow‑up 27 months post‑study entry. No Bria‑IMT‑related discontinuations were reported, and 37 of the 54 patients received the formulation that will be used in the pivotal Phase 3 trial (NCT06072612). The safety profile, combined with durable responses, underscores the therapy’s tolerability and potential for long‑term benefit.
BriaCell’s data reinforce the company’s clinical narrative and support its Fast Track designation from the U.S. FDA, which may accelerate regulatory review. The therapy is an off‑the‑shelf targeted cell‑based immunotherapy that activates antigen‑specific tumor‑killing cells and stimulates the immune system to attack cancer cells. In a market dominated by antibody‑drug conjugates such as Trodelvy and Enhertu, the survival outcomes reported by BriaCell exceed benchmarks for standard‑of‑care regimens in similar patient populations.
Dr. William V. Williams, MD, President & CEO, said, “We look forward to confirming these findings in BriaCell’s ongoing pivotal Phase 3 study with overall survival as its primary endpoint.” Dr. Adam M. Brufsky, Professor of Medicine at the University of Pittsburgh School of Medicine, added, “The two‑year overall survival data ‘shows the possible therapeutic potential of Bria‑IMT regimen for late‑stage MBC, a very difficult‑to‑treat cancer.’”
The Phase 3 top‑line release is slated for the first half of 2026, and the Phase 2 results are expected to inform the design and interpretation of that study. The encouraging survival data may influence investor expectations and position BriaCell as a strong contender in the metastatic breast cancer space, potentially reshaping the competitive landscape and future revenue projections.
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