Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease
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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
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
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Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Company’s ongoing clinical development program for itacitinib, development plans for ruxolitinib and further development in GVHD, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the
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Michael Booth, DPhil
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