BriaCell Provides Phase 3 Clinical Engagement Update in Metastatic Breast Cancer Pivotal Study

Rhea-AI Summary

BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) has provided an update on its pivotal Phase 3 study of Bria-IMT™ in combination with an immune checkpoint inhibitor for metastatic breast cancer (MBC). Key points include:

- 35 clinical sites are actively enrolling patients
- The study will enroll up to 354 patients
- Primary endpoint is overall survival (OS)
- Interim data analysis planned at 144 events (deaths)
- Patient enrollment completion expected by mid-2025
- No serious adverse events related to Bria-IMT™ reported to date

Positive results could lead to full approval and marketing authorization for Bria-IMT™ in MBC patients. The Bria-IMT™ combination regimen has received FDA Fast Track designation.

Positive

• 35 clinical sites actively enrolling patients in Phase 3 study
• Interim data analysis could provide full approval and marketing authorization
• FDA Fast Track designation received for Bria-IMT™ combination regimen
• No serious adverse events related to Bria-IMT™ reported to date

Negative

• Patient enrollment completion not expected until mid-2025
• Interim data analysis requires 144 patient deaths to occur

Insights

Medical Research Analyst

The Phase 3 clinical trial update for BriaCell's Bria-IMT™ combination therapy in metastatic breast cancer (MBC) is a significant development. With 35 active sites enrolling patients and an expected completion of enrollment by mid-2025, the study is progressing as planned. The trial's design, including 354 patients randomized 1:1 to the Bria-IMT™ combination or physician's choice, with a small Bria-IMT™ monotherapy arm, is robust.

The planned interim analysis at 144 events (deaths) is crucial, as positive results could lead to full approval and marketing authorization. This is particularly impactful given the FDA Fast Track designation for the Bria-IMT™ combination regimen. The primary endpoint of overall survival (OS) is a gold standard in oncology trials, which could significantly influence treatment paradigms if successful.

Importantly, the absence of serious adverse events related to Bria-IMT™ to date is encouraging for the therapy's safety profile. However, investors should note that full safety and efficacy data are still pending and the interim analysis results will be critical in determining the therapy's potential market impact.

Oncology Doctor

The progression of BriaCell's Phase 3 trial for Bria-IMT™ in metastatic breast cancer is noteworthy in the oncology field. Breast cancer remains a significant health burden, being the second-leading cause of cancer death in American women. The unmet need in this area underscores the potential impact of a successful immunotherapy.

The combination of Bria-IMT™ with an immune checkpoint inhibitor is a rational approach, leveraging potential synergies in immune activation. The inclusion of a monotherapy arm (n=50) will provide valuable comparative data on the contribution of the checkpoint inhibitor to the regimen's efficacy.

The interim analysis design, focusing on overall survival, aligns with current standards in late-stage oncology trials. If positive, this could accelerate the path to market. However, it's important to note that many promising therapies fail at this stage and the full dataset will be necessary to fully assess the treatment's value. The lack of serious adverse events so far is promising, but ongoing vigilance for safety signals remains essential as the trial progresses.

• 35 sites active and enrolling in pivotal Phase 3 study of Bria-IMT™ combination with immune check point inhibitor in metastatic breast cancer (MBC)
• Primary endpoint is overall survival (OS) with Bria-IMT™ regimen plus Check Point Inhibitor (CPI) vs treatment of physician’s choice
• Interim data analysis planned at 144 events (deaths) could provide full approval and marketing authorization
• Pivotal Phase 3 study patient enrollment completion is expected in mid-2025
• No serious adverse events related to Bria-IMT™ have been reported to date
  

PHILADELPHIA and VANCOUVER, British Columbia, Oct. 15, 2024 (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, today provides a clinical engagement update of its pivotal Phase 3 study of Bria-IMT™ in combination with immune check point inhibitor in metastatic breast cancer (MBC). The study will enroll up to 354 patients randomized 1:1 to the BriaCell combination regimen or physician’s choice and will include a small number (n=50) of patients randomized to Bria-IMT™ monotherapy.

“We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT™ combination regimen in patients with metastatic breast cancer who failed approved therapies,” stated Dr. William V. Williams, BriaCell’s President and CEO.

“Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet.”

35 clinical sites (18 main and 17 satellite) are active and enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.

Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™ in MBC patients. Secondary analyses include comparison of the Bria-IMT™ combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. The Bria-IMT™ combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT™ and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

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: the Company’s beliefs about expected timing and completion of patient enrollment in BriaCell’s pivotal Phase 3 clinical study in metastatic breast cancer and the Company’s future reporting of specific patient enrolment numbers; the Company’s proposed analysis of interim data, and the Company’s belief that such interim data will confirm the effectiveness of the Bria-IMT™ combination regimen in certain patients; the Company’s beliefs regarding the availability of the Bria-IMT™ immunotherapy to patients whose medical needs remain unmet; and the Company’s belief that the results of the Phase 3 study could result in full approval and marketing authorization for Bria-IMT™, 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 

Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com

FAQ

What is the primary endpoint of BriaCell's Phase 3 study for metastatic breast cancer?

The primary endpoint of BriaCell's Phase 3 study for metastatic breast cancer is overall survival (OS), comparing the Bria-IMT™ combination regimen with immune checkpoint inhibitor versus treatment of physician's choice.

How many patients will be enrolled in BriaCell's Phase 3 study for BCTX?

BriaCell's Phase 3 study (BCTX) will enroll up to 354 patients, randomized 1:1 to the BriaCell combination regimen or physician's choice, with a small group (n=50) randomized to Bria-IMT™ monotherapy.

When is the expected completion date for patient enrollment in BriaCell's Phase 3 study?

Patient enrollment completion for BriaCell's Phase 3 study is expected by mid-2025.

What designation has the FDA given to BriaCell's Bria-IMT™ combination regimen?

The FDA has granted Fast Track designation to BriaCell's Bria-IMT™ combination regimen for metastatic breast cancer.