On April 22, 2025 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, reported that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612 ) has consented over 100 and has enrolled over 75 patients (Press release, BriaCell Therapeutics, APR 22, 2025, View Source [SID1234652429]). BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.
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BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice in a dvanced metastatic b reast c ancer (Bria-ABC).
"We are pleased at the expanding patient enrollment in our Phase 3 study, and expect this to continue to grow," stated Dr. William V. Williams, BriaCell’s President & CEO. "We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients, and are determined to bring our novel immunotherapy to market to help these patients."
"Enrollment pace and clinical investigator interest in our Bria-ABC study is above any I have seen," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We would like to thank our dedicated clinical investigators and patients for participating in this important study. Through their efforts, we will advance our novel cancer immunotherapy to other MBC patients whose medical needs remain unmet."
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
Fifty-four clinical sites in the US are actively 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 patient 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. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . 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.