BioNTech Dua,lityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate 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 tumorswith early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer
• The 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 in China, followed by sites in the United States, Europe, and additional regions
• The clinical milestone is in furtherance of BioNTech’s and DualityBio’s strategic objective to advance BNT323/DB-1303 into late-stage development in multiple high unmet medical need cancer indications

https://www.biospace.com/article/releases/biontech-and-dualitybio-initiate-pivotal-phase-3-trial-of-antibody-drug-conjugate-candidate-bnt323-db-1303-in-metastatic-breast-cancer/