BriaCell provides Phase 3 clinical engagement update in MBC study

BriaCell Therapeutics 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. 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 of patients randomized to Bria-IMT monotherapy. 35 clinical sites 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 occur, comparing the overall survival 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(TM) 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.