Rapid Readouts: Safety, Tolerability, and Efficacy of Axatilimab, a CSF-1R humanized antibody, for Chronic Graft-versus-Host Disease after 2 or more Lines of Systemic Treatment
Dr Carrie Lynn Kitko discusses updated results from a phase 1/2 study evaluating the safety, tolerability, and efficacy of axatilimab in pts ≥ 6 years of age with active cGVHD despite ≥ 2 prior lines of systemic therapy.
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Background
Chronic Graft-Versus-Host Disease (cGVHD) affects 30 to 50% of patients who have received allogeneic hematopoietic cell transplantation (HCT). Many patients with cGVHD fail to respond to available therapies or eventually progress. Sclerosis and lung involvement are often difficult to treat and may lead to poor outcomes.
Blocking CSF-1 / CSF-1R signaling may prevent and treat cGVHD
Axatilimab is an anti-CSF-1R monoclonal antibody targeting macrophage-driven diseases
Key clinical features of axatilimab
High-affinity humanized IgG4 monoclonal antibody
Binds to ligand-binding domain on CSF-1R
Blocks the binding of both CSF-1 & IL-34 ligands
Administered via 30-minute infusion every 2 to 4 weeks
Highly effective in selectively reducing levels of circulating pro-fibrotic/non-classical monocytes
Intermittent dosing allows for monocyte recovery prior to subsequent dose