On July 8, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 8, 2025, View Source [SID1234654345]).

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BriaCell’s most recent Phase 2 study cohort of 25 patients* achieved a 52% one-year survival rate (i.e. 52% of patients remained alive at least one year after starting on the study).
11 of these patients remain alive as of most recent contact, including one patient at 38.3 months and another at 30.3 months (see Table 1).
Survival rate exceeds the survival expectations with the current standard of care therapies in similar patient populations (see Table 2).
Notably, many patients had very advanced metastatic breast cancer, having already failed multiple prior lines of therapy including check point inhibitors (CPIs) and antibody-drug conjugates (ADCs) such as TRODELVY – (sacituzumab govitecan-hziy) and ENHERTU (fam-trastuzumab – deruxtecan-nxki).
No treatment discontinuations attributed to Bria-IMT have been reported.
Table 1: Select Long-Term Responders
Patient Months Survival Age Prior Regimens Cycles of Bria-IMT
01-009 38.3 74 5 13
07-001 30.3 55 7; including ENHERTU 8
11-018 21.6 66 8 28
11-019 20.0 63 9; including TRODELVY 6
16-003 19.4 80 5; including ENHERTU 8
"BriaCell’s Phase 2 data indicate a robust survival signal and a well-tolerated profile," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program. "These results reinforce BriaCell’s potential to improve survival and tolerability for late-stage patients."

"Many patients with metastatic breast cancer unfortunately have disease progression despite treatment with CPIs and ADCs," added Aditya Bardia, MD, MPH, FASCO, a leading breast cancer expert. "BriaCell’s survival data in single arm Phase 2 trial highlights the potential activity of Bria-IMT in combination with CPIs and is subject to ongoing investigation in a Phase 3 randomized clinical trial in MBC."

Table 2: Comparable Analysis of One-Year Survival
Reference Breast Cancer Type Median prior lines of therapy Percent Survival at 1 year
Bria-IMT plus CPI All types:
61% HR+
33% TNBC
6% HER2+ 6 52%*
Cortes et al. 1 All types:
57% HR+
18-19% TNBC
18-20% HER2+ 4 ~38-40%
Kazmi et al. 2 All types:
51-52% HR+
25-29% TNBC
9-24% HER2+ 2 30-38%
Bardia et al.
(TPC arm) 3 TNBC 2-3 ~23%
Rugo et al
(TPC arm) 4 HR+ HER2- 2 47%
* 25 patients treated with the Phase 3 formulation since 2022
Cortes J, et al. Annals of Oncology 2018
Kazmi S, et al. Breast Cancer Res Treat. 2020
Bardia A, et al. J Clin Oncol. 2024
Rugo HS, et al. The Lancet. 2023
Abbreviations:

HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor 2 (HER2))
HER2+: Human epidermal growth factor receptor 2 positive
HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC: Treatment of Physicians Choice

BriaCell’s 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 ). Final median overall survival calculation for the Phase 2 study is pending for some sub populations as many patients remain alive. No Bria-IMT-related discontinuations have been reported to date.