Clinical trial examines the effects of immunogenicity on efficacy and safety of axatilimab in chronic graft-versus-host disease patients, indicating minimal impact of ADA and NAb.
Key Points
To evaluate the effects of antidrug antibodies on the pharmacokinetics, pharmacodynamics, efficacy, and safety of axatilimab in patients with cGVHD.
Analyzed data from 319 participants with chronic graft-versus-host disease (cGVHD) including those with treatment-emergent ADA.
Measured pharmacokinetics and pharmacodynamics based on ADA status and neutralizing antibody (NAb) occurrence.
Examined overall response rates and safety events across different ADA and NAb subgroups.
34.2% of participants were treatment-emergent ADA-positive, with most onset within the first month.
No significant differences in pharmacokinetics, efficacy, or safety were found between ADA and NAb subgroups.
Remained consistent nonclassical monocyte levels regardless of ADA or NAb status.