Press release
Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease
- GRAVITAS-301 results show that treatment with itacitinib in combination with corticosteroids did not statistically improve overall response rate or
About this update from Incyte Corporation
[{"type":"text","content":"\n- GRAVITAS-301 results show that treatment with itacitinib in combination with corticosteroids did not statistically improve overall response rate or non-relapse mortality compared to placebo plus corticosteroids\n\n\n- Conference call scheduled today at 5:00 p.m. ET\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte Corporation (Nasdaq:INCY) today announced that the pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD) did not meet the primary endpoint of improving overall response rate (ORR) at Day 28 compared to placebo plus corticosteroids (74.0 percent vs. 66.4 percent, p=0.08, 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.\n\n\nThe safety profile observed in GRAVITAS-301 was consistent with that observed in previously reported studies of itacitinib in combination with corticosteroids. The most common adverse events were thrombocytopenia (34.9 percent for itacitinib and 34.7 percent for placebo) and anemia (29.8 percent for itacitinib and 25.0 percent for placebo).\n\n\n“The result of this study is disappointing. 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,” said Steven Stein, M.D., Chief Medical Officer, Incyte.\n\n\nIncyte 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.\n\n\nAbout GRAVITAS-301\n\n\nGRAVITAS-301 (NCT03139604) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo, in combination with corticosteroid...