What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

To assess the long-term treatment duration and safety of axatilimab in patients with chronic graft-versus-host disease.

December 8, 2025BloodOpen Access

Long-term treatment duration and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-201

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Authors

PHPatrick H. Hardesty DWDaniel Wolff

Discussion

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Overview

Randomised trial evaluated long-term safety and overall survival in refractory chronic graft-versus-host disease, suggesting axatilimab maintains efficacy.

Key Points

To assess the long-term treatment duration and safety of axatilimab in patients with chronic graft-versus-host disease.
Patients aged ≥2 years with cGVHD after ≥2 prior lines of systemic therapy were randomized to receive different dosages of axatilimab.
Treatment continued based on clinical benefit and symptom improvement as assessed by investigators.
Long-term overall survival, safety, and treatment duration were evaluated, focusing on the FDA-approved dosage.
Of the 241 patients enrolled, 239 received axatilimab, with 205 discontinuing treatment for reasons including disease progression and adverse events.
The 46-month overall survival rate was 77.6% for the 0.3 mg/kg Q2W cohort, while 14% of patients continued treatment after 2.8 years.
Common treatment-emergent adverse events included fatigue and increased lab parameters across all doses.

Cite This Study

Hardesty et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d1a2 https://doi.org/10.1182/blood-2025-6010

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December 8, 2025BloodOpen Access

Long-term treatment duration and safety of axatilimab among patients with chronic graft-versus-host disease in AGAVE-201

View Full Paper

Ask AI

Bookmark

Authors

PHPatrick H. Hardesty DWDaniel Wolff

Discussion

Member takes

Overview

Randomised trial evaluated long-term safety and overall survival in refractory chronic graft-versus-host disease, suggesting axatilimab maintains efficacy.

Key Points

To assess the long-term treatment duration and safety of axatilimab in patients with chronic graft-versus-host disease.
Patients aged ≥2 years with cGVHD after ≥2 prior lines of systemic therapy were randomized to receive different dosages of axatilimab.
Treatment continued based on clinical benefit and symptom improvement as assessed by investigators.
Long-term overall survival, safety, and treatment duration were evaluated, focusing on the FDA-approved dosage.
Of the 241 patients enrolled, 239 received axatilimab, with 205 discontinuing treatment for reasons including disease progression and adverse events.
The 46-month overall survival rate was 77.6% for the 0.3 mg/kg Q2W cohort, while 14% of patients continued treatment after 2.8 years.
Common treatment-emergent adverse events included fatigue and increased lab parameters across all doses.

Cite This Study

Hardesty et al. (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d1a2 https://doi.org/10.1182/blood-2025-6010

Also Consider

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

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