BriaCell Highlights Extended >18-47 Months Survival in Phase 2 Metastatic Breast Cancer Patients
Executive Summary
- BriaCell reports that 9 of the 25 Phase 2 patients treated since 2022 remain alive ≥18‑47 months, markedly exceeding historical benchmarks for metastatic breast cancer.
- No Bria‑IMT–related discontinuations have been reported to date; the regimen continues under FDA Fast Track designation.
- Median overall survival (OS) for the post‑2022 cohort is 15.6 months (overall study median OS 13.4 months), compared with 9‑10 months in published comparator studies.
Key Details
- Patient Outcomes:
- 9 long‑term survivors (≥18 months): ages 44–74, median of 5 prior regimens, receiving 6‑35 cycles of Bria‑IMT.
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Highlighted cases:
- Patient 11‑018 (66 y, ER+/PR+/HER2+, 8 prior therapies incl. Enhertu) – complete resolution of brain metastasis, stable bone disease, alive at 27 months post‑enrollment, 35 cycles received.
- Patient 15‑005 (44 y, ER+/PR+/HER2−, 5 prior therapies) – stable disease after 6 cycles, alive at 27 months.
- Patient 15‑006 (64 y, ER+/PR−/HER2−, 8 prior therapies incl. Trodelvy) – liver metastasis, alive at 25 months.
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Study Population: 54 heavily pre‑treated metastatic breast cancer patients (median 6 prior lines).
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37 received the current Phase 3 formulation (25 post‑2022, 12 pre‑2022).
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Survival Metrics:
- Median OS overall: 13.4 months; median OS for post‑2022 cohort: 15.6 months.
- 1‑year survival rate: 52 % (vs. 38‑40 % in Cortes et al., 30‑38 % in Kazmi et al.).
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2‑year survival rate: 32 % (vs. 7‑14 % in Cortes et al., 11‑14 % in Kazmi et al.).
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Comparative Benchmarks: Table of external studies shows Bria‑IMT + CPI OS of 15.6 months exceeds reported medians of 4‑12 months across multiple historic cohorts (Cortes, Kazmi, Bardia, Rugo).
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Regulatory Status: Bria‑IMT regimen maintains FDA Fast Track designation.
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Safety: No discontinuations attributable to Bria‑IMT reported to date.
Notable Quotes
“This two‑year overall survival data shows the possible therapeutic potential of Bria‑IMT regimen for late‑stage MBC… The number of long‑term survivors is quite remarkable… and supports our hypothesis that the Bria‑IMT regimen prolongs survival.” – Dr. William V. Williams, President & CEO, BriaCell Therapeutics
“This two‑year overall survival data shows the possible therapeutic potential of Bria‑IMT regimen for late‑stage MBC, a very difficult‑to‑treat cancer.” – Dr. Adam M. Brufsky, Medical Director, Magee‑Women’s Cancer Program
Materiality Assessment: Material – Positive (significant clinical efficacy data that could impact valuation and future trial expectations).