BriaCell's Phase 2 breast cancer trial shows a 52% one-year survival rate for 25 patients with metastatic breast cancer. The patients had failed multiple prior lines of therapy, including checkpoint inhibitors and antibody-drug conjugates. No treatment discontinuations were attributed to Bria-IMT, and final median overall survival calculation is pending for some sub-populations.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) has announced significant survival data from its Phase 2 clinical study of Bria-IMT in metastatic breast cancer patients. The study, which included heavily pre-treated patients who had previously failed multiple therapies, including checkpoint inhibitors and antibody-drug conjugates, showed that 52% of the most recent 25-patient cohort survived beyond one year, surpassing current standard of care expectations [1].
Notably, 11 patients remain alive, with two remarkable cases reaching 38.3 and 30.3 months of survival. The median number of prior treatments was 6, and importantly, no treatment discontinuations related to Bria-IMT have been reported, suggesting a well-tolerated profile [1].
The Phase 2 data from BriaCell's Bria-IMT therapy represents a significant clinical development in the metastatic breast cancer space. The 52% one-year survival rate stands out particularly because these patients had already failed an average of 6 prior treatment regimens, including advanced therapies like checkpoint inhibitors and antibody-drug conjugates (TRODELVY® and ENHERTU®) [1].
The treatment's safety profile appears favorable with no Bria-IMT-related discontinuations reported - a meaningful advantage in a heavily pre-treated population where treatment toxicity often limits therapeutic options [1]. The ongoing pivotal Phase 3 study (NCT06072612) using the same formulation will be the definitive test of efficacy, as Phase 2 results, while promising, come from a single-arm study with inherent limitations in directly proving causality [1].
This survival signal in patients who have exhausted standard treatments, including modern immunotherapies and ADCs, suggests Bria-IMT may offer a mechanistically distinct approach to overcoming treatment resistance in advanced breast cancer [1].
References:
[1] https://www.stocktitan.net/news/BCTX/bria-cell-phase-2-survival-achievement-52-of-patients-surpass-one-c7dqedbs4fam.html
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