China's Centre for Drug Evaluation (CDE) designated local company Zelgen Biopharm's ZG006, a first-in-class delta-like ligand 3 (DLL3)/CD3 trispecific antibody, as a breakthrough therapy on 9 July for advanced small cell lung cancer (SCLC) patients who failed platinum-based chemotherapy and one or more other systemic therapies. ZG006 simultaneously targets two DLL3 epitopes and CD3 to engage T-cells against tumour cells.

Phase II data presented this year showed a 78.6% objective response rate (ORR) in the 30 mg cohort (n=14) and 53.8% in the 10 mg cohort (n=13), with responses observed even in DLL3-low/-intermediate expressers. ZG006 demonstrated a manageable safety profile, with 12.5% grade ≥3 treatment-related adverse events (TRAEs). The therapy holds orphan drug status in the US and is undergoing global clinical development.