Naval G Daver, Pau Montesinos, Daniel J DeAngelo, Eunice S Wang, Nikolaos Papadantonakis, Elisabetta Todisco, Kendra L Sweet, Naveen Pemmaraju, Andrew A Lane, Laura Torres-Miñana, James E Thompson, Marina Y Konopleva, Callum M Sloss, Krystal Watkins, Gaurav Bedse, Yining Du, Kara E Malcolm, Patrick A Zweidler-McKay, Hagop M Kantarjian
BACKGROUND: Pivekimab sunirine (IMGN632) is a first-in-class antibody-drug conjugate comprising a high-affinity CD123 antibody, cleavable linker, and novel indolinobenzodiazepine pseudodimer payload. CD123 is overexpressed in several haematological malignancies, including acute myeloid leukaemia. We present clinical data on pivekimab sunirine in relapsed or refractory acute myeloid leukaemia. METHODS: This first-in-human, phase 1/2 dose-escalation and dose-expansion study enrolled participants aged 18 years or older at nine hospitals in France, Italy, Spain, and the USA with CD123+ haematological malignancies (Eastern Cooperative Oncology Group performance status of 0-1); participants reported here were in a cohort of participants with acute myeloid leukaemia who were refractory to or had relapsed on one or more previous treatments for acute myeloid leukaemia...
March 2024: Lancet Oncology