On April 16, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients (Press release, BriaCell Therapeutics, APR 16, 2025, View Source [SID1234651969]).
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In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY but still markedly higher (70%) than those of chemotherapy.
"We are truly impressed with the survival benefit data of the regimen that exceeds or meets those of TRODELVY in HR+ and TNBC metastatic breast cancer patients, respectively. Bria-IMT appears to be very well-tolerated," stated Dr. William V. Williams, BriaCell’s President and CEO. "We look forward to further confirming this clinical data in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint."
"HR+ and TNBC metastatic breast cancer represent a significant proportion of the patient population and are the most difficult patient groups to treat. They have limited therapeutic options and overall survival of only a few months," commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "Our clinical data supports our hypothesis that the Bria-IMT regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option."
Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT plus CPI versus other drugs in MBC patient subsets
* Patients treated with the Phase 3 formulation
** Number of prior chemotherapy-containing regimens
1. View Source
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). No Bria-IMT related discontinuations have been reported to date.