BriaCell Therapeutics Corp. announced today that the independent Data Safety Monitoring Board (DSMB) has issued a positive recommendation to continue the company's pivotal Phase 3 clinical trial of Bria-IMT in combination with an immune checkpoint inhibitor for metastatic breast cancer patients.
The DSMB, comprising independent experts who evaluate clinical trial safety data, identified no safety concerns in their second review of the study data and recommended that the trial proceed without modifications. The study (NCT06072612) is currently being conducted under Fast Track Designation from the U.S. Food and Drug Administration (FDA).
"We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor combination in metastatic breast cancer to date," stated Dr. William V. Williams, BriaCell's President and CEO. "The DSMB's second positive data review and recommendation to continue with patient enrollment in BriaCell's pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need."
The Burden of Metastatic Breast Cancer
Metastatic breast cancer remains one of the most challenging forms of cancer, with approximately 168,000 women living with metastatic breast cancer in the United States. Despite advances in treatment options, the 5-year survival rate for metastatic breast cancer is approximately 29%, highlighting the significant unmet need for more effective therapies.
Current treatment approaches typically involve systemic therapies including chemotherapy, hormone therapy, targeted therapies, and immunotherapies. However, resistance to existing treatments often develops, necessitating novel therapeutic approaches.
BriaCell's Innovative Immunotherapy Approach
BriaCell's Bria-IMT is a novel immunotherapy designed to stimulate the immune system to recognize and destroy cancer cells. The combination with immune checkpoint inhibitors aims to enhance this effect by preventing cancer cells from evading immune detection.
The Phase 3 trial is evaluating this combination therapy in patients with metastatic breast cancer who have failed previous treatment regimens. The study design includes rigorous assessment of both safety and efficacy endpoints, with overall survival as the primary outcome measure.
Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer, emphasized the significance of the DSMB's positive review: "Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB's positive review represents an important step forward towards our goal of transforming cancer care, and improving patients' survival and quality of life outcomes. We look forward to sharing additional updates from BriaCell's pivotal Phase 3 trial in the coming months."
Trial Design and Patient Population
The Phase 3 study is a randomized, controlled trial comparing Bria-IMT plus immune checkpoint inhibitor therapy against standard of care treatments. Eligible patients include those with metastatic breast cancer who have progressed after at least one prior line of therapy.
The trial's Fast Track Designation underscores the FDA's recognition of the potential for this treatment to address an unmet medical need in a serious condition. This designation facilitates more frequent interactions with the FDA and may enable expedited review processes.
Looking Toward Future Developments
As the trial progresses, BriaCell plans to provide additional updates on enrollment milestones and interim analyses. The company's approach represents part of a broader trend in oncology toward combination immunotherapies that target multiple aspects of the cancer-immune system interaction.
If successful, this novel immunotherapy combination could potentially offer new hope to patients with limited treatment options, potentially changing the treatment landscape for metastatic breast cancer.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care. The company continues to advance its pipeline of innovative cancer treatments with the goal of improving survival outcomes and quality of life for patients with difficult-to-treat malignancies.
