Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Among patients with recurrent or refractory chronic Graft-Versus-Host Disease (GVHD), Overall Response Rates (ORR)—defined as complete or partial response within the first six cycles—were 74% (95% Confidence Interval [CI]: 63 to 83) in the 0.3 mg dose group, 67% (95% CI: 55 to 77) in the 1 mg dose group, and 50% (95% CI: 39 to 61) in the 3 mg dose group.
• Reduction in chronic GVHD symptom burden, defined as a decrease of more than 5 points on the Modified Lee Symptom Scale, was reported by 60% of patients in the 0.3 mg dose group, 69% in the 1 mg dose group, and 41% in the 3 mg dose group.
• The most common adverse events (AEs) were dose-dependent, transient laboratory abnormalities related to Colony Stimulating Factor 1 Receptor (CSF1R) blockade. Discontinuation due to AEs occurred in 6% of patients in the 0.3 mg dose group, 22% in the 1 mg dose group, and 18% in the 3 mg dose group.
• There is no population type or subgroup information available in the reviewed studies.