Incyte has announced updated results from its Phase III study evaluating itacitinib (formerly INCB039110) in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD).
The company revealed that the drug combo did not meet the primary endpoint of improving overall response rate compared to placebo – with the data coming in at 74.0% vs. 66.4%.
Ultimately the drug improved the overall response rate in patients with treatment-naïve acute GVHD; however, the difference versus placebo plus corticosteroids was not statistically significant.
There was also no difference observed in non-relapse mortality (NRM) at six months, the study’s key secondary endpoint, between the treatment and placebo arms.
The results are being hailed as “disappointing”, by Steven Stein, chief medical officer of the company. He went on to say: “However, we remain committed to building on the success of the REACH program for ruxolitinib, which showed positive results in steroid refractory acute GVHD.
“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.”
Following on from the setback, Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient.
The company also announced that data from this study will be submitted for presentation at an upcoming scientific meeting.
