Itacitinib fails to meet primary endpoint in phase III GRAVITAS-301 study to treat graft-versus-host disease.- Incyte Corpn.

Incyte Corporation announced that the pivotal Phase III 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. The 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).