BriaCell’s Bria-IMT™ Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer
Rhea-AI Summary
BriaCell Therapeutics (NASDAQ: BCTX) has reported promising Phase 2 survival data for its Bria-IMT™ immunotherapy in combination with checkpoint inhibitors for metastatic breast cancer treatment. The study showed significant survival advantages over Trodelvy® and control groups:
In triple negative breast cancer (TNBC), Bria-IMT achieved median overall survival of 13.9 months, surpassing Trodelvy (11.8 months) and doubling control group (6.9 months). For hormone receptor positive (HR+) patients, Bria-IMT reached 17.3 months median survival versus Trodelvy's 14.4 months and control's 11.2 months.
The Phase 2 study included 54 heavily pre-treated patients who had received a median of 6 prior therapies. Notably, no Bria-IMT related treatment discontinuations were reported, and the company is currently conducting a pivotal Phase 3 study.
Positive
- Bria-IMT showed superior survival rates compared to both Trodelvy and control groups in TNBC and HR+ patients
- No treatment-related discontinuations reported, indicating good safety profile
- Impressive results despite patients having failed median of 6 prior therapies
- Survival advantage demonstrated in multiple breast cancer subtypes
- Phase 3 pivotal trial already ongoing with same formulation
Negative
- Study involved relatively small patient population (54 patients)
- Patients required combination therapy with checkpoint inhibitors
- Phase 2 results still need validation in larger Phase 3 trial
News Market Reaction 1 Alert
On the day this news was published, BCTX declined 2.42%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months)
- OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months)
- No treatment related discontinuations reported
PHILADELPHIA and VANCOUVER, British Columbia, July 11, 2025 (GLOBE NEWSWIRE) -- 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, today announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI).
The data show a meaningful survival advantage in heavily pretreated metastatic breast cancer (MBC) patient subtypes:
- Triple negative breast cancer (TNBC): median overall survival (OS) of 13.9 months vs. 11.8 months for antibody drug conjugate Trodelvy (sacituzumab govitecan-hziy) and 6.9 months single agent chemotherapy data. BriaCell’s median OS has improved from 11.4 months last reported at ASCO in June 2025.1
- Hormone receptor positive (HR+): median overall survival (OS) of 17.3 months vs. 14.4 months for Trodelvy and 11.2 months in single agent chemotherapy data.
“We are thrilled to see our Bria-IMT regimen outperform established benchmarks like Trodelvy in TNBC and HR+ MBC patients,” stated Dr. William V. Williams, BriaCell’s President and CEO. “BriaCell’s patients had failed a median of six prior therapies, underscoring the potential clinical impact of our novel immunotherapy. We look forward to validating these findings in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint.”
| Table 1: Analysis of survival data for BriaCell’s Phase 2 study versus Trodelvy in MBC patient subsets | |||||
| Breast Cancer Type | Treatment | Median # of prior lines of therapy | Median Overall Survival (months) | Survival rate at 6 months (%) | Survival rate at 12 months (%) |
TNBC | Bria-IMT plus CPI* | 6 | 13.9 | 78 | 56 |
TNBC | Trodelvy1 (sacituzumab govitecan-hziy) | 3** | 11.8 | 80*** | 49*** |
| Single agent chemotherapy | 3** | 6.9 | 56*** | 22*** | |
HR+ | Bria-IMT plus CPI* | 6 | 17.3 | 90 | 61 |
HR+ | Trodelvy1 (sacituzumab govitecan-hziy) | 4 | 14.4 | 83*** | 61 |
| Single agent chemotherapy | 4 | 11.2 | 76*** | 47 | |
| * Patients treated with the Phase 3 formulation ** Prior chemotherapy-containing regimens *** Derived from published Kaplan-Meier curves see1 1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf | |||||
Abbreviations:
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))
- As shown in table 1, median OS number with Bria-IMT is higher than that reported in the treatment arm of the ASCENT study (SG) for TNBC patients, and twice that reported in treatment of physician’s choice arm.
HR+: hormone receptor-positive
The Phase 2 Bria-IMT 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 received the same 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 validating positive findings in its ongoing pivotal Phase 3 study with overall survival as its primary endpoint, 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
1https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
FAQ
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