Pivekimab Sunirine: A Novel CD123 ADC Showing Promise for BPDCN

Sangeetha Venugopal, MD, MS, discusses pivekimab sunirine (PVEK), a novel CD123-targeting antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm (BPDCN). PVEK showed promising response rates in treatment-naïve BPDCN patients in an early trial and was reasonably well-tolerated without concerning safety signals. Its FDA breakthrough therapy designation in relapsed/refractory BPDCN was based on phase 1 data suggesting good efficacy even after tagraxofusp (TAG). Early trials also support PVEK's potential in CD123+ acute myeloid leukemia, both as monotherapy and when combined with other agents like azacitidine and venetoclax.