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December 8, 2025BloodOpen Access

Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007

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Authors

HEHarry P. ErbaDuke UniversityCMChristine M. McMahonUniversity of Colorado Anschutz Medical CampusTBTalha BadarJacksonville College

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Implication

Phase 1a/b trial shows safety and clinical activity of ziftomenib with venetoclax and azacitidine in relapsed/refractory AML patients.

Key Points

  • To evaluate the safety and clinical activity of ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory acute myeloid leukemia.
  • Open-label phase 1a/b study of adults with relapsed/refractory NPM1-m or KMT2A-r AML.
  • Patients treated with ziftomenib 600 mg once daily plus standard doses of venetoclax and azacitidine.
  • Primary endpoints included adverse events, complete remission, and dose limiting toxicities.
  • 80 patients enrolled, median age 63 years, with significant treatment-emergent adverse events.
  • Overall response rates were 65% for NPM1-m and 33% for KMT2A-r.
  • Complete remission with full hematologic recovery rates were 49% for NPM1-m and 22% for KMT2A-r.

Cite This Study

Erba et al. (2025) studied this question.

synapsesocial.com/papers/693624d44fa91c937236d086https://doi.org/10.1182/blood-2025-764
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-0072025 · 10 citations
  2. 2Phase 1/2, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, and efficacy of Zefamenib combined with chemotherapy or targeted Agents in patients with Acute Myeloid Leukemia2025
  3. 3Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute Myeloid Leukemia2025 · 6 citations
  4. 4A pre-emptive bridge-to-transplant therapy for measurable residual disease with venetoclax and azacitidine in NPM1-mutated Acute Myeloid Leukemia: Updates from the ongoing GIMEMA AML2521 phase 2 trial2025
  5. 5Revumenib for patients with relapsed or refractory (R/R) Nucleophosmin 1–Mutated (NPM1m) Acute Myeloid Leukemia (AML): Outcomes by prior treatment in the phase 2 AUGMENT-101 study2025 · 1 citations