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Axatilimab + corticosteroids is a combination regimen under clinical investigation as initial therapy for moderate or severe chronic graft-versus-host disease (cGVHD), including bronchiolitis obliterans syndrome. Axatilimab is a monoclonal antibody targeting the colony-stimulating factor 1 receptor (CSF1R), thereby modulating the monocyte-macrophage lineage implicated in cGVHD pathogenesis, providing immunosuppressive effects distinct from T-cell–directed therapies. Corticosteroids (such as prednisone, methylprednisolone, or prednisolone) are standard first-line immune suppressants that act broadly by inhibiting multiple pro-inflammatory pathways. The combination aims to offer improved efficacy or enable steroid-sparing strategies for newly diagnosed cGVHD patients. The regimen is being evaluated in phase 3 randomized, placebo-controlled trials and investigated for safety and efficacy in cGVHD, including steroid-refractory cases. Axatilimab is developed and manufactured by Incyte.
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