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December 8, 2025BloodOpen Access

Pharmacodynamic analysis of AGAVE-201 indicates changes in CSF-1R–expressing cells and associated biomarkers potentially contributing to chronic graft-versus-host disease resolution

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Authors

ICIan M. CatlettBBBreann BarkerSLSong Lou

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Overview

Phase 2 trial reveals axatilimab improves biomarkers in cGVHD, suggesting immune modulation via monocytes and macrophages.

Key Points

  • To assess pharmacodynamic changes in monocytes and biomarkers in patients with chronic graft-versus-host disease treated with axatilimab.
  • Analyzed circulating monocytes and serum proteome in 241 patients from AGAVE-201 trial.
  • Monocytes were classified using flow cytometry and CD45+ → CD14+ HLA-DR+ markers.
  • Serum cytokine levels (CSF-1 and IL-34) measured by ELISA and proteomic analysis performed using OLINK Explore HT.
  • Increased serum levels of CSF-1 and IL-34; decreased non-classical monocytes with axatilimab treatment.
  • Identified 193 and 47 differentially expressed proteins at 1 mg/kg; 504 and 304 at 3 mg/kg at specified cycles.
  • Significant reductions in cell surface markers CD163 and CD300E, correlated to immune regulation and potential fibrosis resolution.

Cite This Study

Catlett et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e20chttps://doi.org/10.1182/blood-2025-2458
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