BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer

BioNTech and DualityBio announced that their Phase 3 DYNASTY-Breast02 trial met its primary endpoint, showing statistically significant but modest improvement in progression-free survival with trastuzumab pamirtecan versus chemotherapy in HR+/HER2-low metastatic breast cancer patients. However, a higher rate of interstitial lung disease was observed, and the companies noted limited potential benefit in the current treatment landscape.