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December 8, 2025BloodOpen Access

Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-007

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Authors

KPKeith W. PratzSidney Kimmel Comprehensive Cancer CenterJBJames S. BlachlyThe Ohio State University Wexner Medical CenterAQAyman QasrawiUniversity of Kentucky

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Implication

Phase 1b trial shows 84% complete remission in newly diagnosed NPM1-m AML with ziftomenib and venetoclax/Azacitidine, indicating strong activity.

Key Points

  • Evaluate the safety and clinical activity of ziftomenib with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia.
  • Phase 1b clinical trial
  • Adults with newly diagnosed NPM1-m AML not eligible for intensive chemotherapy
  • Patients received ziftomenib 600 mg plus standard doses of venetoclax and azacitidine
  • Assessment of complete remission, composite remission, and local measurable residual disease
  • 84% composite complete remission rate observed at a median of 3.5 weeks
  • 54% CRc MRD-negativity rate at 8.4 weeks
  • 74% of patients experienced grade ≥3 treatment-emergent adverse events
  • Median follow-up was 16.3 weeks with ongoing trial activity

Cite This Study

Pratz et al. (2025) studied this question.

synapsesocial.com/papers/693624d44fa91c937236d05dhttps://doi.org/10.1182/blood-2025-766
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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 relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-0072025 · 9 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. 3Phase 1a/1b study of the safety, pharmacokinetics, and antitumor activity of ziftomenib in combination with imatinib in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure.2026
  4. 4Preliminary 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 · 8 citations
  5. 5A 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