QSP Modeling to Support Development of Ziftomenib Combinations in Acute Myeloid Leukemia

Authors: Meaney C, Markazi A, Leoni M, Mitra A
Conference: ACoP
Keywords: ACoP 2026, acute myeloid leukemia, QSP modeling, ziftomenib

Objective

  • Ziftomenib is a potent, selective, oral menin inhibitor that is U.S. FDA-approved as monotherapy at 600mg QD for adults with relapsed/refractory (R/R) NPM1-m AML and no other satisfactory treatments.
  • It has shown clinical activity and tolerability in combination with venetoclax/azacitidine (ven/aza) and cytarabine/daunorubicin (7+3) standard-ofcare (SOC) chemotherapies in adults with newly diagnosed (ND) or R/R, NPM1-m or KMT2A-r AML
  • KOMET-007 (NCT05735184) is an ongoing, multi-cohort, open-label, Phase (Ph) 1a/b (dose-escalation and -expansion) study of ziftomenib combined with SOC therapies, including ven/aza and 7+3, in adults with NPM1-m or KMT2A-r AML
  • A QSP model of AML progression was developed and used to characterize the efficacy and safety of these ziftomenib combinations, to support further development

By Cameron Meaney, Ashley Markazi, Ryan Suderman, Mollie Leoni, Amitava Mitra

ACoP 2026, October 11-14, 2026, National Harbor, Maryland