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Results from a phase I/II trial of rovadicitinib for SR/SD cGvHD
Treatment with corticosteroids remains the standard first-line treatment in patients with cGvHD. However, ~50% of patients experience treatment failure, and there remains an unmet need for effective treatments for these steroid-refractory patients.1 A phase Ib/IIa, multicenter, open-label trial (NCT04944043) assessed the safety and efficacy of rovadicitinib, a novel, oral dual JAK1/2 and ROCK1/2 inhibitor in patients with moderate or severe glucocorticoid-refractory or -dependent cGvHD.1 The primary endpoints of the trial were safety and recommended phase II dose, with best overall response (BOR) as the key secondary endpoint. In total, 44 patients were enrolled across two cohorts receiving 10 mg twice daily (n = 29) and 15 mg twice daily (n = 15). Results were published in Blood by Zhao et al.1
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Key learnings |
| The recommended phase II dose was determined as 10 mg twice daily. The BOR was 86.4%, with no difference in BOR between doses. The BOR was higher in the steroid-dependent cohort (90.9%) vs the steroid-refractory cohort (72.7%). |
| In general, rovadicitinib was well tolerated. There were no dose-limiting toxicities at either dose, and no rovadicitinib-related AEs led to discontinuation. The majority of AEs were Grade 1 or 2; most common AEs included anemia, upper respiratory tract infection, and Epstein-Barr virus. |
| At 12 months, the failure-free survival rate was 85.2%, and 88.6% of patients were able to reduce corticosteroid dose. Regardless of prior therapy, responses were observed in all affected organs, and 59.1% of patients experienced an improvement in cGvHD symptoms. |
| Rovadicitinib treatment leads to dual inhibition of inflammatory and fibrotic pathways in GvHD, representing a novel therapeutic approach. The findings from this trial demonstrate the efficacy and safety of rovadicitinib in steroid-refractory or -dependent cGvHD, and warrant further investigation in further studies with larger patient cohorts. |
Abbreviations: AE, adverse event; BOR, best overall response; cGvHD, chronic graft-versus-host disease; GvHD, graft-versus-host disease; JAK, Janus kinase; ROCK, Rho-associated protein kinase.
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