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December 8, 2025BloodOpen Access

Axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic graft-versus-host disease: Interim safety analysis of a phase 2, randomized study

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Authors

RZRobert ZeiserAIAnnie ImAAAlbert Assad

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Overview

Interim analysis shows combination therapy improves outcomes in patients with cGVHD, indicating potential effectiveness.

Key Points

  • Assess the safety of axatilimab combined with ruxolitinib in patients with newly diagnosed cGVHD.
  • Ongoing phase 2, randomized, open-label study with newly diagnosed cGVHD patients.
  • Patients aged ≥12 years with moderate or severe cGVHD and no prior systemic treatment were recruited.
  • Participants were randomized to receive axatilimab with ruxolitinib, ruxolitinib alone, or corticosteroids for up to 24 months.
  • As of the interim analysis, 44 patients were enrolled, with 43 receiving treatment.
  • Combined therapy was well tolerated, with 32 patients reporting treatment-emergent adverse events.
  • No evidence of additive toxicity from the axatilimab and ruxolitinib combination.

Cite This Study

Zeiser et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d199https://doi.org/10.1182/blood-2025-6012
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Also Consider

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

  1. 1Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program2025 · 1 citations
  2. 2An open-label phase I study of JAK inhibitor ruxolitinib with and without CTLA-4 ig abatacept for the prophylaxis of graft-versus-host ddsease and cytokine release syndrome after T-cell replete haploidentical peripheral blood hematopoietic cell transplantation2025
  3. 3Long-term treatment duration and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-2012025 · 1 citations
  4. 4Impact of ruxolitinib on corticosteroid treatment patterns in 1147 patients with chronic graft-versus-host disease in real-world practice in the United States: A long-term follow-up analysis2025
  5. 5Pharmacodynamic analysis of AGAVE-201 indicates changes in CSF-1R–expressing cells and associated biomarkers potentially contributing to chronic graft-versus-host disease resolution2025