Phase III clinical failure of Jak1 inhibitor GVHD

Today, Incyte announced that its selective Jak1 inhibitor itacitinib failed to reach the trial end point in a phase III clinical trial of acute graft-versus-host disease (GVHD) called gravitas-301 In this study, we compared the response rates of itacitinib and placebo on the background of steroids for 28 days in patients who had not received treatment before Results the response rates of the two groups were 74% and 66%, respectively, which failed to reach statistical differentiation A key secondary end point, 6-month non recurrent mortality, was also not differentiated between the two groups Incyte closed down 10% today GVHD is a serious side effect of allogeneic stem cell transplantation and the most common non recurrent lethal factor, because the donor's immune cells attack the recipient's various tissues Acute GVHD has many symptoms, including digestive tract, skin and liver, while chronic GVHD is mainly skin allergic reaction This is a relatively rare disease with unknown incidence rate 10-50% is estimated to have GVHD in patients undergoing stem cell transplantation There is no reliable biomarker for assessing risk Itacitinib also has a phase III clinical trial called gravitas-309 for chronic GVHD in progress Incyte has a Jak1 / JAK2 dual inhibitor ruxolitinib approved for use in acute GVHD second-line patients with hormone relapse through the accelerated approval channel This product is also in the validation phase III clinical trial of chronic GVHD and acute GVHD.