Incyte announced results from the pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD). The study did not meet the primary endpoint or the key secondary endpoint.
GRAVITAS-301 was a randomized, double-blind, placebo-controlled pivotal study evaluating itacitinib or placebo, in combination with corticosteroids, as a first-line treatment for patients with acute GVHD. The study did not meet the primary endpoint of improving overall response rate (ORR) at Day 28 compared to placebo plus corticosteroids (74% vs. 66.4%, respectively). Itacitinib added to corticosteroids improved the overall response rate in patients with treatment-naïve acute GVHD; however, the difference versus placebo plus corticosteroids was not statistically significant. In addition, there was no difference observed in non-relapse mortality (NRM) at Month 6, the study’s key secondary endpoint, between the treatment and placebo arms.
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. Data from this study will be submitted for presentation at an upcoming scientific meeting.
Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor.
About Graft vs. Host DiseaseGraft-versus-host disease (GVHD) is a potentially serious complication of allogeneic stem cell transplantation and reduced-intensity allogeneic stem cell transplantation. During allogeneic stem cell transplantation, a patient receives stem cells from a donor or donated umbilical cord blood. GVHD occurs when the donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign, and attack and damage them. Graft-versus-host disease can be mild, moderate or severe. In some cases, it can be life-threatening.Source: Incyte