BioNTech and DualityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Metastatic Breast Cancer

The pivotal Phase 3 trial with BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 ("HER2")-expressing advanced solid tumors with early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancerThe trial is expected to enroll 532 patients with Hormone Receptor-positive ("HR+") and HER2-low metastatic breast cancer progressing on hormone therapy at clinical trial sites worldwide, initially ...