Dr. William Williams reports
BRIACELL'S PHASE 3 PATIENT ENROLLMENT ON TRACK FOR 1H2026 TOPLINE DATA READOUT
Briacell Therapeutics Corp.'s phase 3 clinical study has screened over 230 and enrolled over 160 patients. Briacell anticipates reporting top-line data as early as H1 2026.
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Over 230 patients screened and over 160 patients enrolled in Briacell's pivotal phase 3 study in metastatic breast cancer (MBC);
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Enrolment exceeding expectations with strong clinical site and patient interest;
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Top-line interim data readout expected in H1 2026;
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Phase 3 combination regimen continues under FDA (Food and Drug Administration) fast-track designation.
Interim data will be analyzed once 144 patient events (deaths) occur. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer.
Briacell's pivotal phase 3 clinical study is evaluating Briacell's lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus physician's choice in advanced metastatic breast cancer (Bria-ABC).
"The pace of patient enrollment in our pivotal phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators," stated Dr. William V. Williams, Briacell's president and chief executive officer. "We look forward to collecting, analyzing and sharing the phase 3 data with the U.S. FDA in the coming months as we continue working to bring hope to patients with metastatic breast cancer who face an urgent medical need."
About Briacell's pivotal phase 3 clinical study of Bria-IMT combination regimen in MBC patients
Briacell's pivotal phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data from Briacell's continuing pivotal phase 3 study of Bria-IMT plus an immune check point inhibitor in metastatic breast cancer will be analyzed once 144 patient events (deaths) occur. This interim analysis will assess overall survival (OS) as the primary end point, comparing patients treated with the Bria-IMT combination regimen with those receiving physician's choice therapy. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has been granted FDA fast-track designation.
About Briacell Therapeutics Corp.
Briacell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care.
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