In a phase 2 trial, presented at the 64th ASH Annual Meeting and Exposition, researchers compared itacitinib monotherapy against systemic corticosteroids (SCS) in the treatment of patients with graft-versus-host disease (GVHD) at low risk for treatment failure. According to the study’s authors, itacitinib induced faster responses with similar durability and significantly reduced infection risks compared with SCS.
The trial enrolled 70 patients with low-risk GVHD to receive itacitinib 200 mg daily over a 28-day cycle, after which successful responders could receive a second cycle. Investigators constructed a matched cohort of 140 control patients from the Mount Sinai Acute GVHD International Consortium database who were treated with standard doses of SCS (median starting dose, 1.1 mg/kg). End points included objective response rate (ORR) at day 28 and serious infections.
Itacitinib Yields Faster Response Versus Corticosteroids
Researchers reported that itacitinib and SCS treatment produced “excellent” ORRs of 89% and 86%, respectively (P=.67), even in patients with lower gastrointestinal GVHD. The authors noted that ORR was comparably high across all subgroups, and responses were durable up to 90 days
Of note, significantly more patients treated with itacitinib showed a response by day 7 compared with SCS controls (81% vs 66%; P=.02). Responses were durable in both groups up to 90 days, and there were no significant differences in relapse rate at 1 year.
In addition, itacitinib monotherapy was associated with significantly less severe cases of leukopenia and reduced incidence of serious infections compared with SCS, “likely as a result of dramatically less exposure to systemic steroids,” the authors explained.
The authors concluded that itacitinib monotherapy was an effective primary treatment in patients with low-risk GVHD, and they proposed further studies on itacitinib in this population.
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