BriaCell Highlights 16.6-Month Median OS and Preserved QOL in Phase Trials
BriaCell's Phase 2 Bria-IMT study in heavily pre-treated metastatic breast cancer patients showed median overall survival of 16.6 months with the Phase 3 formulation and a 52% 12-month survival rate. Phase 3 Bria-ABC trial data revealed preserved quality of life, no treatment-related discontinuations and showed DTH positivity and CTC <5 predicted longer survival.
1. Phase 2 Bria-IMT Results
In a Phase 2 study of 32 heavily pretreated metastatic breast cancer patients aged 41–80 with a median of six prior therapies, the selected Phase 3 Bria-IMT formulation achieved a median overall survival of 16.6 months, a 52% 12-month survival rate and no treatment-related discontinuations.
2. Phase 3 Bria-ABC Trial Data
Interim blinded data from the ongoing pivotal Phase 3 Bria-ABC trial combining Bria-IMT with an immune checkpoint inhibitor showed stable global health scores, preserved functional domains and no unexpected safety signals in patients previously exposed to ADCs, CPIs and CDK4/6 inhibitors.
3. Biomarkers Predicting Response
Analyses demonstrated that patients with positive delayed-type hypersensitivity responses had median OS of 11.9 versus 4.7 months, and baseline circulating tumor cell counts below five correlated with OS of 16.6 versus 5.5 months, supporting DTH and CTC levels as predictive markers.
4. Next Steps and Clinical Impact
BriaCell will continue follow-up to characterize durability of patient-reported outcomes, unblind Phase 3 efficacy data after 144 mortality events, and explore decentralized care models and second-generation BC1 immunotherapy in upcoming expansion cohorts.