BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer
Rhea-AI Summary
BriaCell Therapeutics (Nasdaq: BCTX) has announced promising Phase 2 survival data for its Bria-IMT™ treatment in metastatic breast cancer patients. The study showed a median overall survival of 17.3 months in hormone receptor positive (HR+) patients, surpassing TRODELVY®'s 14.4 months in similar heavily pre-treated cases.
The Phase 2 trial included 54 patients with a median of 6 prior treatments. Of these, 37 received the current Phase 3 formulation, with 25 identified as HR+ breast cancer patients. In triple negative breast cancer (TNBC) patients, Bria-IMT showed comparable results to TRODELVY® with 11.4 months versus 11.8 months survival, both significantly higher than chemotherapy's 6.9 months.
Notably, no Bria-IMT related discontinuations have been reported in the ongoing pivotal Phase 3 study (NCT06072612), suggesting good tolerability.
Positive
- Superior survival rate in HR+ breast cancer: 17.3 months vs TRODELVY's 14.4 months
- Comparable efficacy to TRODELVY in TNBC patients (11.4 vs 11.8 months)
- 70% higher survival rate compared to chemotherapy in TNBC patients
- Zero treatment-related discontinuations reported
Negative
- Heavily pre-treated patient population (median 6 prior treatments) may limit market potential
- TNBC results slightly lower than TRODELVY (11.4 vs 11.8 months)
Insights
BriaCell's Phase 2 data represents a potentially significant advancement in treating hormone receptor positive (HR+) metastatic breast cancer patients. The 17.3-month median overall survival surpasses TRODELVY®'s 14.4 months by approximately 20% in heavily pre-treated patients who had received a median of 6 prior therapies.
What's particularly compelling is the efficacy maintained despite the patient population being more heavily pre-treated than in TRODELVY®'s trials (6 vs 4 prior lines). This suggests Bria-IMT could be effective even in later treatment lines where options are typically and outcomes poor.
For triple-negative breast cancer (TNBC), while not showing superiority over TRODELVY®, Bria-IMT demonstrated comparable survival (11.4 vs 11.8 months) and substantially outperformed chemotherapy (11.4 vs 6.9 months). This dual efficacy across different breast cancer subtypes expands the potential patient population.
The clean safety profile with no treatment-related discontinuations is remarkable and critically important for late-stage cancer patients. This tolerability advantage could position Bria-IMT as a more patient-friendly alternative to antibody-drug conjugates like TRODELVY® that often carry significant toxicity profiles.
With their pivotal Phase 3 trial already underway using overall survival as the primary endpoint, these data significantly de-risk BriaCell's clinical program. The immunotherapy approach appears particularly promising for HR+ patients who typically have fewer targeted therapy options after hormone therapy resistance develops.
- Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patients
- Survival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY®
- No Bria-IMT related discontinuations reported to date
PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (GLOBE NEWSWIRE) -- 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, announces 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.
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 (
“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 | |||
| Reference | Breast Cancer Type | Median # of prior lines of therapy | Median OS (months) |
| Bria-IMT plus CPI* | HR+ | 6 | 17.3 |
| TRODELVY®1 (sacituzumab govitecan-hziy) | HR+ | 4 | 14.4 |
| Single agent chemotherapy | 4 | 11.3 | |
| Bria-IMT plus CPI* | TNBC | 6 | 11.4 |
| TRODELVY®1 (sacituzumab govitecan-hziy) | TNBC | 3** | 11.8 |
| Single agent chemotherapy | 3** | 6.9 | |
| * Patients treated with the Phase 3 formulation ** Number of prior chemotherapy-containing regimens | |||
| 1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf | |||
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.
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 further confirming positive clinical data in its ongoing pivotal Phase 3 study; BriaCell’s further clinical development of Bria-IMT™; the Company’s beliefs regarding the results of BriaCell’s pivotal Phase 3 study; and the Company’s beliefs 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, 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, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
FAQ
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