BriaCell Phase 2 Bria-IMT Regimen Yields 16.6-Month Median Survival and 55% 1-Year OS
BCTX•BriaCell’s Phase 2 Bria-IMT plus checkpoint inhibitor regimen yielded a median overall survival of 16.6 months in the Phase 3 formulation population, with 55% 1-year and 27% 2-year OS and cycle-one CPI initiation boosting 12- and 24-month OS to 50% and 25%. Safety was favorable with no treatment discontinuations.
1. Phase 2 Bria-IMT Clinical Results
BriaCell’s Phase 2 study of Bria-IMT with checkpoint inhibitor evaluated two dosing sequences and formulations in heavily pretreated metastatic breast cancer patients (median six prior therapies). Patients on the Phase 3 formulation achieved a median overall survival of 16.6 months with 55% alive at one year and 27% at two years.
2. Impact of CPI Sequencing
Initiating the immune checkpoint inhibitor in the first treatment cycle improved median OS to 13.3 months versus 7.4 months when delayed to cycle two, with 50% and 25% survival at 12 and 24 months, respectively, supporting the cycle-one approach chosen for the Bria-ABC trial.
3. Safety and Tolerability
The Bria-IMT regimen was well tolerated; the most common adverse events were mild injection site reactions, there were no treatment-related discontinuations or unexpected safety signals, and quality-of-life measures remained stable during therapy.
4. Biomarker Insights and Phase 3 Implications
Delayed-type hypersensitivity positivity and lower baseline circulating tumor cell counts correlated with extended survival, guiding ongoing biomarker validation, and these findings reinforce the continued use of the current formulation in the pivotal Phase 3 Bria-ABC study.
