BriaCell's Phase 2 Study Exceeds Expectations with 52% One-Year Survival Rate in Metastatic Breast Cancer

BriaCell's Phase 2 study in metastatic breast cancer patients shows 52% of patients surpassing the one-year survival milestone, exceeding standard expectations. 11 patients remain alive, with two cases reaching significant survival milestones of 38.3 and 30.3 months. Bria-IMT demonstrates a well-tolerated safety profile with no treatment discontinuations. The study provides a strong foundation for BriaCell's upcoming Phase 3 study.

BriaCell Therapeutics Corp. (BCTX) has announced significant survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer (MBC). The study, involving 25 patients, achieved a 52% one-year survival rate, surpassing current standard-of-care expectations [1].

Eleven of these patients remain alive as of the most recent follow-up, with two patients achieving remarkable survival milestones of 38.3 and 30.3 months [2]. The study included heavily pre-treated patients who had previously failed multiple therapies, including checkpoint inhibitors and antibody-drug conjugates. 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 [3].

The survival benefit observed in heavily pre-treated populations, including those who progressed after checkpoint inhibition and antibody drug conjugates, highlights the potential of Bria-IMT in combination with checkpoint inhibitors. The study's results reinforce BriaCell’s potential to improve survival and tolerability for late-stage patients [1].

The upcoming pivotal Phase 3 study (NCT06072612) 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. 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 [3].

References:
[1] https://www.nasdaq.com/articles/briacell-announces-52-one-year-survival-rate-metastatic-breast-cancer-study
[2] https://www.cancernetwork.com/view/bria-imt-yields-updated-survival-benefit-in-metastatic-breast-cancer
[3] https://www.stocktitan.net/news/BCTX/bria-cell-phase-2-survival-achievement-52-of-patients-surpass-one-c7dqedbs4fam.html