Incyte announced 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.

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).

"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.

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.

GRAVITAS-301 (NCT03139604) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo, in combination with corticosteroids, as a first-line treatment for patients with acute GVHD. The primary endpoint is overall response rate (ORR) at Day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. The key secondary endpoint is non-relapse mortality at Month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse. Other secondary endpoints include duration of response. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2.

Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD.

Itacitinib was discovered at Incyte, and Incyte holds the global development and commercialization rights for itacitinib with the exception of China, where the rights to develop and commercialize itacitinib have been licensed to Innovent Biologics.

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