BioNTech SE and its partner Duality Biologics announced a Phase III interim analysis showing that their HER2-targeting antibody-drug conjugate (trastuzumab pamirtecan) met the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane chemotherapy. This breakthrough marks BioNTech's first Phase III oncology success and positions Duality Biologics to pursue regulatory approval in China following its successful China-based trial. The milestone reinforces the therapeutic potential of HER2 ADCs in difficult-to-treat breast cancers and sets the stage for global regulatory submissions and future clinical development.