Exposure-Response Relationships for Axatilimab in Patients with Chronic Graft-Versus-Host Disease.

ABSTRACT: Axatilimab, a high-affinity humanized monoclonal antibody that targets colony-stimulating factor 1 receptor, is approved for the treatment of chronic graft-versus-host disease (cGVHD). Here, we describe the exposure-response relationships for efficacy and safety in patients with cGVHD who received axatilimab. Exposure-efficacy relationships were assessed in treated patients in the AGAVE-201 study (n = 239); exposure-safety relationships were assessed in treated patients in AGAVE-201 (n = 239) and the phase 1/2 SNDX-6352-0503 study (n = 39). For binary or time-to-event endpoints, logistic or Cox regression analyses, respectively, were performed using axatilimab exposure metrics that were derived from a previously developed population pharmacokinetic/pharmacodynamic model. Overall response a

SUBMITTER: Yang YO 

PROVIDER: S-EPMC12439004 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature