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December 8, 2025Blood

Subgroup analyses from the randomized, Phase 3 VERONA study of venetoclax with azacitidine (Ven+Aza) versus placebo with azacitidine (Pbo+Aza) in patients with treatment-naïve, intermediate and higher-risk Myelodysplastic Syndromes (HR MDS)

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Authors

GGGuillermo Garcia‐ManeroPFPierre FenauxMHMarek Hus

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Overview

Randomized trial found subgroup trends favoring venetoclax and azacitidine in treatment-naïve patients with HR MDS, suggesting clinical benefits.

Key Points

  • To identify patient subsets that may benefit from venetoclax combined with azacitidine in higher-risk myelodysplastic syndromes.
  • Randomized, phase 3 trial comparing venetoclax with azacitidine to placebo with azacitidine.
  • Enrolled patients aged ≥18 with treatment-naïve, higher-risk MDS, not suitable for immediate SCT.
  • Primary endpoint was overall survival, with subgroup analyses for survival and modified overall response.
  • No significant difference in overall survival between treatment groups (22.18 months vs. 21.68 months).
  • Higher modified overall response rate with venetoclax and azacitidine (76.2%) compared to placebo (57.7%).
  • Subgroup trends favoring venetoclax observed in younger patients and those with specific mutations.

Cite This Study

Garcia‐Manero et al. (2025) studied this question.

synapsesocial.com/papers/69362f5d4fa91c937236dc6chttps://doi.org/10.1182/blood-2025-235
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Also Consider

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

  1. 1Results from paradigm - a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia2025 · 33 citations
  2. 2Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)2025
  3. 3Venetoclax and azacytidine in childhood primary advanced myelodysplastic syndromes, refractory/relapsed Acute Myeloid Leukemia and therapy-related myeloid diseases2025
  4. 4Addition of Venetoclax to Azacitidine Did Not Improve Survival in Acute Myeloid Leukemia and Was Not Well Tolerated: Real World Experience2026
  5. 5Outcomes of patients (pts) with higher-risk myelodysplastic syndromes (HR-MDS) treated with hypomethylating agents (HMA) + venetoclax (VEN) – a large analysis from the international consortium for MDS (icMDS) validate database2025