ASH 2025 | Pivekimab sunirine + Ven + Aza in unfit patients with ND CD123+ AML: Phase Ib/II efficacy and safety

Following the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, the AML Hub was pleased to speak with Gail Roboz, Weill Cornell Medicine, New York, US. We asked, What are the latest findings from clinical trials of pivekimab sunirine in unfit patients with newly diagnosed acute myeloid leukemia (AML)?

In this interview, Roboz discusses key findings from a preliminary subgroup analysis of a phase Ib/II trial (NCT04086264), investigating the anti-CD123 antibody–drug conjugate pivekimab sunirine in combination with azacitidine and venetoclax, for ≥14 days or 28 days, in unfit patients with newly diagnosed CD123-positive AML. The primary endpoint was antileukemic activity, including complete remission (CR) and composite CR with incomplete hematologic recovery (CR/CRi) rates.

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