What type of study is this?

This is a Human Clinical Trial study.

What question did this study set out to answer?

To evaluate the safety and feasibility of changing dosing of axatilimab from 0.3 mg/kg to 0.6 mg/kg every 4 weeks.

December 8, 2025Blood

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Clinical trial demonstrates high response rate in patients with cGVHD transitioning to axatilimab 0.6 mg/kg Q4W, pointing to sustained benefit.

To evaluate the safety and feasibility of changing dosing of axatilimab from 0.3 mg/kg to 0.6 mg/kg every 4 weeks.
Patients with cGVHD transitioned from 0.3 mg/kg Q2W to 0.6 mg/kg Q4W based on treatment response and protocol criteria.
Safety and duration of treatment were evaluated in a post hoc analysis, excluding those on additional therapies.
The primary endpoint was patient response within the first 6 treatment cycles.
73.8% of patients showed a response to 0.3 mg/kg Q2W treatment during the first 6 cycles.
94.7% response rate observed in patients switching to 0.6 mg/kg Q4W dosing.
Patients maintained treatment for a median of 20.9 months after switching doses with an 84% continuation rate.
Ten patients experienced grade ≥3 treatment-emergent adverse events, with pneumonia noted in 2 cases.

Maria Sola Soto (2025) studied this question.

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December 8, 2025Blood

View Full Paper

Ask AI

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Authors

Clinical trial demonstrates high response rate in patients with cGVHD transitioning to axatilimab 0.6 mg/kg Q4W, pointing to sustained benefit.

To evaluate the safety and feasibility of changing dosing of axatilimab from 0.3 mg/kg to 0.6 mg/kg every 4 weeks.
Patients with cGVHD transitioned from 0.3 mg/kg Q2W to 0.6 mg/kg Q4W based on treatment response and protocol criteria.
Safety and duration of treatment were evaluated in a post hoc analysis, excluding those on additional therapies.
The primary endpoint was patient response within the first 6 treatment cycles.
73.8% of patients showed a response to 0.3 mg/kg Q2W treatment during the first 6 cycles.
94.7% response rate observed in patients switching to 0.6 mg/kg Q4W dosing.
Patients maintained treatment for a median of 20.9 months after switching doses with an 84% continuation rate.
Ten patients experienced grade ≥3 treatment-emergent adverse events, with pneumonia noted in 2 cases.

Maria Sola Soto (2025) studied this question.

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