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- 9 of 25 BriaCell patients treated since 2022 remain alive >18-47 months post enrollment, markedly exceeding benchmarks reported for standard of care therapies in similar patient populations
- No Bria-IMT™ related discontinuations reported to date
- Bria-IMT regimen continues under Fast Track Designation from US FDA
briacell therapeutics corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces new positive Phase 2 survival data highlighting multiple patients surpassing expected benchmarks for metastatic breast cancer and survival length over 18 months in 9 cases as of their last assessment.
| Table 1: Ongoing Long-Term Survivors | ||||
| Patient/Subtype | Months Since Study Start | Age | Number of Prior Regimens | Cycles of Bria-IMT |
| 01-009/ER+/PR+/HER2low | 47 | 74 | 5 | 14 |
| 07-001/ER+/PR+/HER2low | 30 | 55 | 7 | 8 |
| 15-001/ER+/PR-/HER2- | 30 | 62 | 3 | 12 |
| 11-018/ER+/PR+/HER2+ (Highlighted below) | 27 | 66 | 8; including ENHERTU | 35 |
| 15-005/ER+/PR+/HER2- (Highlighted below) | 27 | 44 | 5 | 6 |
| 15-006/ER+/PR-/HER2- (Highlighted below) | 25 | 64 | 8; including TRODELVY | 4 |
| 15-004/ER+/PR+/HER2- | 25 | 50 | 3 | 6 |
| 11-019/ER+/PR+/HER2low | 23 | 63 | 9; including TRODELVY | 6 |
| 07-014/ER+/PR+/HER2low | >18 | 62 | 9; including TRODELVY | 5 |
| Note that Trodelvy and Enhertu are antibody-drug conjugates recently approved for late-stage breast cancer. | ||||
Select patients are highlighted here in further detail:
Patient 11-018: 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer with 8 prior therapies including an antibody-drug conjugate (Enhertu). She presented with metastatic involvement of the right orbit (behind the right eye), the right temporal lobe of the brain, and multiple skeletal sites. She experienced complete resolution of the temporal lobe metastasis, substantial improvement in the orbital lesion and stable disease in the bone. She was on study 26 months after initiating treatment receiving 35 cycles of therapy. She remains in survival follow-up 27 months post-enrollment.
Patient 15-005: 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer and 5 prior therapies. She presented with a metastasis to the spine and completed 6 cycles of therapy achieving stable disease as her best response. She remains in survival follow-up 27 months after entering the study.
Patient 15-006: 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer and 8 prior therapies including the antibody-drug conjugate Trodelvy. She presented with a metastasis to the liver, and remained in survival follow-up 25 months post-enrollment.
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 stated, "This two-year overall survival data shows the possible therapeutic potential of Bria-IMT regimen for late-stage MBC, a very difficult-to-treat cancer. Heavily pretreated metastatic breast cancer remains an unmet medical need with few to no treatment options and limited lifespan for many patients."
"Our drive to generate long term data reflects our belief that clinicians and cancer patients deserve clear, meaningful evidence to guide their treatment decisions. The number of long-term survivors is quite remarkable, given how heavily pre-treated these patients are, and supports our hypothesis that the Bria-IMT regimen prolongs survival in patients with metastatic breast cancer," stated Dr. William V. Williams, BriaCell's President and CEO. "We look forward to confirming these findings in BriaCell's ongoing pivotal Phase 3 study with overall survival as its primary endpoint."
| Table 2: Comparable analysis of 1- and 2-year survival for the BriaCell Phase 2 study using the Phase 3 formulation since 2022 independent of subsequent treatment | |||||
| Reference | Breast cancer type | Median prior lines of therapy | Median OS (months) | % Survival at: | |
| 1 year | 2 years | ||||
| Bria-IMT ™ plus CPI | All types 61% HR+ 33% TNBC 6% HER2+ | 6 | 15.6 | 52% | 32% |
| Cortes et al.1 | All types 57% HR+ 18-19% TNBC 18-20% HER2+ | 4 | 9.1-9.3 | ~38-40% | 7-14% |
| Kazmi et al.2 | All types 51-52% HR+ 25-29% TNBC 9-24% HER2+ | 2 | 7.2-9.8 | 30-38% | 11.9-14% |
| Bardia et al. (TPC)3 | TNBC | 4 | 6.9 | ~23% | 6% |
| Bardia et al. (Trodelvy)3 | TNBC | 4 | 11.8 | 50% | 21% |
| Rugo et al (TPC)4 | HR+ HER2- | 4 | 11.2 | 47% | 21% |
| Rugo et al (Trodelvy)4 | HR+ HER2- | 4 | 14.4 | 60% | 25% |
| 1. Cortes J, et al. Annals of Oncology 2018 (estimated from Kaplan-Meier curve) 2. Kazmi S, et al. Breast Cancer Res Treat. 2020 3. Bardia A, et al. J Clin Oncol. 2024 (estimated from Kaplan-Meier curve) 4. Rugo HS, et al. The Lancet. 2023 (estimated from Kaplan-Meier curve) 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 receptor 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 | |||||
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median of six prior therapies) treated with the Bria-IMT regimen plus a checkpoint inhibitor. Of these, 37 patients received the same formulation currently being evaluated in the pivotal Phase 3 trial (NCT06072612), including 25 treated post 2022 and 12 treated pre 2022. Median overall survival across these cohorts, including those pre 2022 is 13.4 months and post 2022 alone 15.6 months. Significantly, 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 those about the potential outcomes of the Phase 2 data, the therapeutic potential of Bria-IMT regimen for late-stage MBC, and BriaCell's ongoing pivotal Phase 3 study 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.
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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
