Expanding the Treatment Landscape for Steroid-Refractory cGVHD Care With Axatilimab
A panelist discusses how axatilimab is particularly effective for patients with bronchiolitis obliterans syndrome, showing response rates of almost 50% with 20% complete responses, and offers the advantage of reliable intravenous delivery despite logistical challenges of infusion center visits.
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Axatilimab, now commercially available for patient use, is particularly valuable for patients with chronic graft-vs-host (cGVHD) who have progressed or plateaued on prior treatments like ibrutinib or ruxolitinib. The treatment goal is to deepen responses, recapture previous improvements, and enhance quality of life. One particularly promising application is in bronchiolitis obliterans syndrome (BOS), a severe form of cGVHD affecting 10% to 15% of patients, characterized by progressive decline in lung function due to small airway inflammation. While most approved cGVHD drugs demonstrate limited efficacy for BOS, the AGAVE-201 study showed impressive response rates of approximately 50% in patients with lung involvement, with 20% achieving complete responses based on pulmonary function tests or National Institutes of Health symptom scores.
The intravenous administration of axatilimab presents both advantages and challenges. While patients must visit infusion centers regularly, creating logistical hurdles compared with oral medications, the parenteral delivery ensures reliable administration and adherence. This benefit is significant since nonadherence to complex medication regimens is common among patients with cGVHD who take multiple drugs. The reliable intravenous administration guarantees that patients receive their prescribed medication, though downsides include the need for vascular access and the small risk of infusion reactions. However, severe infusion reactions occur in only 1% to 2% of patients, with most experiencing either no reaction or manageable grade 1/2 reactions that respond to antihistamines and antipyretics.
Axatilimab represents an important therapeutic option with a unique mechanism targeting the monocyte-macrophage pathway, distinct from other approved agents that primarily affect T cells. This distinctive mechanism of action creates potential for novel combination approaches in both relapsed/refractory and frontline settings. Ongoing clinical trials are investigating corticosteroid-free interventions for moderate to severe cGVHD, including a randomized phase 2 study comparing steroids alone vs steroids plus axatilimab, and a phase 3 trial evaluating axatilimab alone vs axatilimab with corticosteroids to determine if upfront combination therapy produces deeper responses in newly diagnosed patients.
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