BioNTech and Duality Biologics begin Phase 3 trial of breast cancer candidate

BioNTech and Duality Biologics announced that the first patient with metastatic breast cancer has been treated in a pivotal Phase 3 trial evaluating the efficacy and safety of the next-generation antibody-drug conjugate candidate BNT323/DB-1303 targeting the Human Epidermal Growth Factor Receptor 2 – HER2 -, a cancer cell surface protein. The Phase 3 trial will assess the efficacy and safety of BNT323/DB-1303 compared to standard-of-care single-agent chemotherapy in chemotherapy-naive patients with HR+ and HER2-low metastatic breast cancer that have progressed on hormone therapy. The trial is expected to enroll 532 patients at more than 223 clinical sites worldwide. The study’s primary endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, and safety. The Phase 3 trial is based on positive safety and efficacy data from a Phase 1/2 study which demonstrated encouraging anti-tumor activity in heavily pretreated patients with HER2-low breast cancer with an objective response rate of 38.5% and a disease control rate of 84.6%. BioNTech and DualityBio’s strategic objective is to advance the product candidate into late-stage development in multiple high unmet medical need cancer indications. BioNTech and DualityBio’s collaboration initiated in April 2023. BioNTech will hold commercial rights globally excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region, while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.