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December 8, 2025Blood

PyramIDH: A phase 3 study of ivosidenib monotherapy or azacitidine monotherapy in patients with mutant isocitrate dehydrogenase 1 myelodysplastic syndromes who have not received prior hypomethylating agent therapy

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Authors

UPUwe PlatzbeckerUBUma BoratePPPrapti A. Patel

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Overview

Phase 3 trial compares ivosidenib vs azacitidine in patients with myelodysplastic syndromes, suggesting potential implications for treatment strategies.

Key Points

  • To confirm the safety and efficacy of ivosidenib monotherapy in HMA-naive patients with mIDH1 MDS.
  • Phase 3, multicenter, open-label, randomized study
  • Patients with mIDH1 MDS randomized to IVO or AZA monotherapy
  • Primary endpoint is CR+PR rate at 4 months according to IWG 2006 criteria
  • CR+PR rates for IVO monotherapy in previous studies were reported at 38.9% and 72%
  • Safety profile of IVO demonstrated acceptable levels
  • Randomization stratified by IPSS-M risk category

Cite This Study

Platzbecker et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e1f7https://doi.org/10.1182/blood-2025-8254
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Also Consider

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

  1. 1Ivosidenib Monotherapy Is Effective in Patients with IDH1 Mutated Myelodysplastic Syndrome (MDS): The Idiome Phase 2 Study By the GFM Group2021 · 46 citations
  2. 2Final phase 1 substudy results of ivosidenib for patients with mutant <i>IDH1</i> relapsed/refractory myelodysplastic syndrome2024 · 49 citations
  3. 3A phase II study of IDH1 inhibition with ivosidenib as maintenance therapy after ivosidenib, azacitidine, and venetoclax for Acute Myeloid Leukemia: Trial in progress2025
  4. 4Real life study of ivosidenib in either monotherapy or combined with azacytidine for first line mutant IDH1 AML: A study from the french AML intergroup ALFA/filo2025 · 1 citations
  5. 5Updated response and safety analyses from a Phase 1 study of ivosidenib combined with intensive chemotherapy in patients with newly diagnosed (ND) Acute Myeloid Leukemia with isocitrate dehydrogenase (IDH)1 mutation2025 · 2 citations