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# Incyte Transplant Drug Disappoints in Phase 3
- URL: https://www.fdaweb.com/incyte-transplant-drug-disappoints-in-phase-3/
- Published: 2020-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:57:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145769

Incyte says its 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 compared to placebo plus corticosteroids. Itacitinib added to corticosteroids improved the overall response rate, but the difference versus placebo plus corticosteroids was not statistically significant, the company says. In addition, it says there was no difference observed in non-relapse mortality at six months, the study’s key secondary endpoint between the treatment and placebo arms.

Itacitinib is described by Incyte as a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. It was discovered by Incyte, which holds the therapy’s global development and commercialization rights except China, where such rights have been licensed to Innovent Biologics.