- Disease control rate of 61% observed in evaluable Phase 2 patients treated with the same formulation in BriaCell’s pivotal Phase 3 study
- Disease control rate of 50% in evaluable patients treated with the Phase 3 formulation who failed prior antibody-drug conjugate (ADC) therapy
- Notable responder had failed 4 prior therapies including ADC therapy with metastatic liver tumor “no longer observed” following BriaCell treatment
“We are extremely pleased to report clinical benefit with our regimen in a heavily pre-treated patient who had failed prior ADC treatment,” commented Dr.
“We are beyond excited by the clinically significant disease control data we are seeing in this group of very difficult-to-treat patients,” stated Dr.
Case Report of a Notable Responder in Prior ADC Therapy Failure
Background: Advanced metastatic breast cancer patients who have had multiple lines of prior treatments including ADCs, are often recommended palliative, supportive medical care that focuses on easing pain, stress and other symptoms of a serious/terminal illness.
The patient was hormone receptor positive HER 2 negative (HR+/HER2-), had failed four prior lines of therapy including ADC therapy and had breast cancer metastasized to her liver. She had two HLA matches with Bria-IMT™ and received seven cycles of treatments with the Bria-IMT™ regimen.
Results: In her first on study assessment the liver metastasis was no longer seen. She had progression free survival (PFS) of 5.8 months, a 100% increase from her PFS on ADC therapy.
BriaCell Clinical Data in Evaluable Patients
Bria-IMT™ Combined with an Immune Check Point Inhibitor
Among the 35 patients with evaluable outcomes in BriaCell’s ongoing Phase 2 study, 23 patients were treated with the same Bria-IMT™ formulation currently being used in BriaCell’s Phase 3 metastatic breast cancer study. These patients had been heavily pre-treated and had failed a median number of six prior regimens.
Results in Evaluable Patients:
- Disease control rate of 61%; defined as the percentage of patients who achieve a complete response, partial response, or stable disease.
- Disease control rate of 50% in the 10 patient subset who had failed prior ADC therapy. This compares favorably with reported literature for second ADC treatment in ADC failure patients (~20-42%)1.
- Progression free survival of 4.2 months in ADC failure patients is also very favorable in comparison to published data in similar patients (1.6-3.3 months)1.
- No discontinuations due to drug toxicity reported.
- No cases of Interstitial Lung Disease (ILD) with Bria-IMT™ (a well-documented serious side effect of ADCs) reported in this group of patients.
The strong survival and clinical benefits observed in evaluable and ADC resistant patients support the use of the current formulation in BriaCell’s pivotal Phase 3 study and the Company looks forward to presenting further updates as treatment progresses in the fully enrolled Phase 2 study.
About
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 Bria-IMT™ approach being a promising therapeutic alternative to chemotherapy in advanced metastatic breast cancer; BriaCell's ability to continue their ongoing pivotal Phase 3 study enrollment; BriaCell's Bria-IMT™ approach providing both survival and quality of life benefits to patients; BriaCell sharing additional clinical data with the public in the coming months; and BriaCell presenting further updates as treatment progresses in the fully enrolled Phase 2 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
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Contact Information
Company Contact:
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1-888-485-6340
info@briacell.com
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