What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

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

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 reports long-term safety in patients with chronic graft-versus-host disease receiving axatilimab, suggesting clinical benefit from prolonged treatment.

Key Points

To report the long-term treatment duration and safety of axatilimab in patients with chronic graft-versus-host disease (cGVHD).
Patients aged ≥2 years with refractory or recurrent cGVHD were randomised to receive axatilimab at different dosages.
Treatment continued based on clinical benefit assessment by investigators.
Long-term overall survival, safety, and treatment duration were assessed, focusing on the axatilimab 0.3 mg/kg Q2W cohort.
Of 241 patients enrolled, 239 received axatilimab with various dosing schedules.
The 46-month overall survival rate was 77.6% for the 0.3 mg/kg Q2W cohort.
Treatment-emergent adverse events were reported, with fatigue and increased lab parameters as common occurrences.

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 reports long-term safety in patients with chronic graft-versus-host disease receiving axatilimab, suggesting clinical benefit from prolonged treatment.

Key Points

To report the long-term treatment duration and safety of axatilimab in patients with chronic graft-versus-host disease (cGVHD).
Patients aged ≥2 years with refractory or recurrent cGVHD were randomised to receive axatilimab at different dosages.
Treatment continued based on clinical benefit assessment by investigators.
Long-term overall survival, safety, and treatment duration were assessed, focusing on the axatilimab 0.3 mg/kg Q2W cohort.
Of 241 patients enrolled, 239 received axatilimab with various dosing schedules.
The 46-month overall survival rate was 77.6% for the 0.3 mg/kg Q2W cohort.
Treatment-emergent adverse events were reported, with fatigue and increased lab parameters as common occurrences.

Cite This Study

Hardesty et al. (2025) studied this question.

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

View Full Paper

Ask AI

Bookmark