Elfetabart drozuntecan (BNT324/DB-1311)
Overview
A next-generation, topoisomerase-1-inhibitor-based antibody-drug conjugate targeting the immune-checkpoint protein B7-H3, co-developed with China's DualityBio - BioNTech's third late-stage oncology asset alongside BNT327 and trastuzumab pamirtecan, with clinical experience across more than ten tumor types.
First patient dosed in May 2026 in BNT324-03, a global pivotal Phase 3 trial (target enrollment 736 patients) versus docetaxel in taxane-naive metastatic castration-resistant prostate cancer (mCRPC), following a median radiographic progression-free survival of 11.3 months in heavily pretreated mCRPC patients. The FDA has granted the candidate Fast Track designation in mCRPC. At WCLC 2026, first combination data with pumitamig in SCLC posted a 70.4% ORR across 71 evaluable patients.