BioNTech says trastuzumab pamirtecan met primary endpoint in Phase 3 trial

BioNTech (BNTX) and Duality Biologics announced that the pivotal Phase 3 trial which DualityBio is conducting in China to evaluate trastuzumab pamirtecan versus trastuzumab emtansine in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of progression free survival at a pre-specified interim analysis. This is the first positive Phase 3 data readout achieved in BioNTech’s and DualityBio’s strategic collaboration initiated in April 2023. The collaboration aims to accelerate the development of differentiated ADC therapeutics for solid tumors. In January 2024, the partners initiated a global Phase 3 DYNASTY-Breast02 trial program for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer following positive Phase 1/2 safety and efficacy data in patients with HER2-expressing advanced solid tumors. BioNTech holds global commercial rights — excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region — while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. “This is a milestone in the fruitful collaboration with our colleagues at DualityBio,” said Prof. Ozlem Tureci, M.D., Chief Medical Officer and Co-Founder at BioNTech.