BriaCell Phase 2 Survival Achievement: 52% of Patients Surpass One-Year Milestone in Metastatic Breast Cancer
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% TNBC6% HER2+
6
52%*
Cortes et al.1
All types: 57% HR+ 18-19% TNBC18-20% HER2+
4
~38-40%
Kazmi et al.2
All types: 51-52% HR+ 25-29% TNBC9-24% 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:
hormone receptor-positive Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor 2 (HER2)) Human epidermal growth factor receptor 2 positivehormone receptor-positive and human epidermal growth factor receptor 2 negative 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.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including statements about: BriaCell's potential to improve survival and tolerability for late-stage metastatic breast cancer patients; the impact of Bria-IMT™ on patients with metastatic breast cancer; and BriaCell's further clinical development of Bria-IMT™ are based on BriaCell's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading 'Risks and Uncertainties' in the Company's most recent Management's Discussion and Analysis, under the heading 'Risk Factors' in the Company's most recent Annual Information Form, and under 'Risks and Uncertainties' in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact: William V. Williams, MDPresident & CEO 1-888-485-6340 info@briacell.com
Investor Relations Contact: investors@briacell.comSign in to access your portfolio
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