The FDA approved BriaCell Therapeutics’ (NASDAQ:BCTX; TSX: BCT) pivotal registrational study design for Bria-IMT in combination with a checkpoint inhibitor in advanced metastatic breast cancer, including the study design, the primary and secondary endpoints, and patient population.
The trial will be a randomized, open-label study comparing the Bria-IMT combination regimen with an immune check point inhibitor in one arm with treatment of physicians’ choice in another arm in advanced metastatic breast cancer.
A third smaller arm with the Bria-IMT regimen alone will be included in the study to address the FDA’s combination drug assessment requirements. Patient recruitment and dosing will commence in summer 2023.
On achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT combination regimen following the biologics licensing application filing process.
“A successful study may significantly transform the approach to treat advanced breast cancer,” Dr. Giuseppe Del Priore, CMO of BriaCell, said in a statement.
