Rovadicitinib and glucocorticoid-refractory or -dependent cGVHD
Zhao Y, Luo Y, Shi J, et al. A First-in-Class JAK/ROCK Inhibitor, Rovadicitinib, for Glucocorticoid-Refractory or -Dependent Chronic GVHD. Blood. 2025; (doi: 10.1182/blood.2024026581).
Rovadicitinib demonstrates therapeutic potential for patients whose chronic graft-versus-host disease (cGVHD) is glucocorticoid-refractory or -dependent, researchers report. The dual JAK1/2 and ROCK1/2 inhibitor, the first of its kind, works by blocking inflammatory and fibrotic pathways present in cGVHD. Safety and efficacy were evaluated in a Phase Ib/IIa trial that included 29 participants treated with 10 mg twice per day and 15 participants treated with 15 mg twice daily. After finding that rovadicitinib was well-tolerated at both amounts, with no adverse events leading to discontinuation, the second part of the study proceeded using the 10-mg dose. Investigators shifted focus to the key secondary endpoint: best overall response, estimated at 86.4% with both doses of rovadicitinib. That benchmark was reached by 72.7% of the steroid-refractory patients and by 90.9% of the steroid-dependent participants. The failure-free survival rate was 85.2% at 1 year. Overall, rovadicitinib improved quality of life by lowering corticosteroid demand in 88.6% of patients and alleviating cGVHD-related symptoms in 59.1%.