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Incyte's drug stumbles at Phase 3 in treatment-naive acute graft-versus-host disease

Published on 06/01/20 at 09:47am

Drugmaker Incyte has made it known that its selective JAK1 inhibitor therapy itacitinib fell short at Phase 3 in the treatment of previously untreated acute graft-versus-host disease (GVHD) when combined with corticosteroids.

The company revealed that the combo failed to adequately improve overall response rate (ORR) after 28 days of treatment, scoring 74% overall in trial participants compared to 66.4% with placebo plus corticosteroids.

This meant that, while improvement was observed, the benefit was not of clinical significance, resulting in the trial failing to meet its primary endpoint.

However, the study did manage to hit its secondary endpoint, with no difference observed in non-relapse mortality after six months of treatment between the two combinations.

“The result of this study is disappointing. However, we remain committed to building on the success of the REACH programme for ruxolitinib, which showed positive results in steroid refractory acute GVHD,” commented Dr Steven Stein, Chief Medical Officer at Incyte. “Additionally, we will continue to study the role of JAK inhibition in chronic GVHD and in the prophylactic setting, as we seek to develop treatments for patients with this debilitating and often fatal disease.”

Incyte confirmed that full data from the study is due to be presented at an upcoming scientific conference.

Matt Fellows

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