BriaCell Reports Unprecedented Preliminary Survival and Clinical Benefit in Antibody-Drug Conjugate (ADC) Refractory Patient Subset
- Unprecedented preliminary survival and clinical benefit data
- Median OS up to twice that reported in the literature
- Disease control rate of 40% observed in evaluable patients
- None.
The data presented by BriaCell Therapeutics Corp. on the Bria-IMT™ regimen for advanced breast cancer patients resistant to Antibody-Drug Conjugates (ADCs) is a significant stride in oncology. The reported median Overall Survival (OS) up to twice that of existing literature and a Disease Control Rate (DCR) of 40% in evaluable patients are noteworthy. These outcomes suggest a potential improvement in survival outcomes for a patient population with limited options.
Furthermore, the absence of Interstitial Lung Disease (ILD) as a side effect, which is commonly associated with ADCs, indicates a favorable safety profile for the Bria-IMT™ regimen. This could represent a substantial advancement in the treatment landscape for metastatic breast cancer, particularly for those who have undergone multiple prior therapies.
From a research perspective, the preliminary findings from BriaCell's ongoing Phase 2 study are promising. The Kaplan-Meier analysis revealing extended median OS and the 40% of patients experiencing similar or better Progression Free Survival (PFS) compared to their last regimen, provide initial evidence of Bria-IMT™'s efficacy. However, it is important to consider the sample size and the maturity of the data, as ongoing studies could yield more definitive results.
Investors and stakeholders should monitor the continued progression of this study, as further positive results could impact the company's valuation and stock performance. Additionally, the potential for Bria-IMT™ to address a significant unmet medical need in ADC-refractory breast cancer patients could lead to expedited regulatory pathways and partnerships.
Looking at the broader oncology market, the advancement of immunotherapies like Bria-IMT™ is disruptive. ADCs have been a prominent treatment modality, but their limitations due to side effects and resistance underscore the need for alternative therapies. BriaCell's promising clinical data positions the company as a potential key player in the breast cancer immunotherapy niche, which could attract strategic collaborations or acquisitions.
Moreover, the absence of toxicity-related discontinuations in the Bria-IMT™ treatment cohort is significant, potentially leading to better patient compliance and outcomes. As the industry shifts towards personalized and more tolerable treatments, BriaCell's approach could set a new standard for patient care in this challenging subset of breast cancer.
- In the subset of Antibody-Drug Conjugate (ADC) refractory patients, Overall Survival (OS) data of BriaCell’s combination regimen exceeded that of similar studies*
- Progression Free Survival (PFS) was similar or better than last regimen in
40% of the patients highlighting clinical efficacy - Disease control rate of
40% was observed in evaluable patients further indicating clinical benefit
PHILADELPHIA and VANCOUVER, British Columbia, Dec. 20, 2023 (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, is pleased to report unprecedented preliminary survival and clinical benefit data in a new subset of advanced breast cancer patients treated with BriaCell’s Bria-IMT™ regimen: patients that have developed resistance to (and failed to respond to) Antibody-Drug Conjugates (“ADC”, “ADCs”).
ADCs have significantly advanced cancer therapy in the past few years; however many patients experience serious side effects and others develop resistance to ADCs; therefore, their medical needs remain unmet.
“We are excited with our findings of unprecedented survival and clinical benefit in very difficult-to-treat patients who failed ADCs and view our findings as a significant clinical breakthrough in the field of cancer therapy. This is highly encouraging given our ongoing pivotal study is investigating the effects of Bria-IMT™ regimen in advanced breast cancer with overall survival as its primary endpoint,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Armed with our novel immunotherapy, we are hoping to make a meaningful contribution to the lives of patients who have failed ADCs across all breast cancer types.”
BriaCell Clinical Data in ADC Refractory Patients
Bria-IMT™ Combined with an Immune Check Point Inhibitor
- In a subset of BriaCell’s ongoing Phase 2 study, clinical data of 23 advanced metastatic breast cancer patients who failed prior treatments with ADCs were analyzed. Four patients had prior treatments with KADCYLA®; 13 had prior treatments with ENHERTU®, 13 with TRODELVY®, of which 7 of these patients were treated with multiple agents (totaling 23 patients). In addition, 7 of these 23 patients had also failed prior treatment with immune checkpoint inhibitors.
- Heavily pre-treated metastatic breast cancer patients had a median number of 6 prior treatments.
- Kaplan-Meier analysis showed median overall survival (OS) that was up to twice that reported in the literature, with some patients recording survival of over a year.
- Disease control rate of
40% was observed in evaluable patients further indicating clinical benefit. - Progression free survival (PFS) was similar or better than that of the patients’ prior therapy in
40% of patients, highlighting clinical benefit and tolerability of the Bria-IMT™ regimen. - 17 of 23 patients remain alive as of today, suggesting efficacy, tolerability, and survival benefit of BriaCell’s Bria-IMT™ regimen. The data will continue to mature as patients remain on the study.
- All patients received BriaCell’s therapy with no toxicity related discontinuations.
- Importantly, there were no cases of Interstitial Lung Disease (ILD) with Bria-IMT™ – a well-documented serious side effect of ADCs.
* Laura Huppert et al., Multicenter retrospective cohort study of the sequential use of the antibody-drug conjugates (ADCs) trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in patients with HER2-low metastatic breast cancer (MBC) (PS08-04) - SABCS 2023
* François Poumeaud et al., Efficacy of Sacituzumab-Govitecan (SG) post Trastuzumab-deruxtecan (T-DXd) and vice versa for HER2low advanced or metastatic breast cancer (MBC): a French multicentre retrospective study. (PS08-02) - SABCS 2023
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 presented in today’s press release, 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.sedar.com 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
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
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