Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host
Disease
Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in GRAVITAS-301, a pivotal Phase 3
trial for the first-line treatment of patients with acute graft-versus-host disease (GVHD). The trial will evaluate the efficacy
and safety of itacitinib, Incyte’s novel, potent, and selective JAK1 inhibitor, in combination with corticosteroids compared to
placebo plus corticosteroids in patients with acute GVHD.
“Today, there are no approved treatment options for acute GVHD, a severe and life-threatening condition that can lead to tissue
damage, organ failure, and death in certain transplant recipients,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “The
initiation of the GRAVITAS-301 trial represents an important milestone for Incyte as we continue to progress our clinical
development portfolio, and we look forward to further evaluating the potential of itacinitib to address the unmet needs of patients
with this potentially devastating condition.”
GVHD is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or
tissue), whereby the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body.
GVHD can be acute or chronic, and is a significant cause of morbidity and mortality in transplant recipients. The skin,
gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with acute GVHD.
About GRAVITAS-301
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 study will enroll
approximately 430 patients 18 years or older who have undergone one allogeneic transplant from any donor and any donor source for a
hematologic malignancy or disorders. The primary endpoint of the GRAVITAS-301 study 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. Key
secondary endpoints include non-relapse mortality at Month 6, defined as the proportion of subjects who died due to causes other
than malignancy relapse, duration of response, and ORR at Day 14, 56, and 100. For more information about the study, please
visit https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2.
About Itacitinib
Itacitinib (INCB039110) is a novel, potent, and selective JAK1 inhibitor currently in clinical studies for the treatment of
treatment naïve GVHD and non-small cell lung cancer.
Global development and commercialization rights for itacitinib are wholly-owned by Incyte.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website
at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements
regarding the Company’s plans and expectations for the GRAVITAS-301 program, 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 and the risks related to
the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of
risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic
factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with
the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2017. Incyte disclaims any intent
or obligation to update these forward-looking statements.
Incyte Corporation
Media
Catalina Loveman, +1 302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1 302-498-5914
mbooth@incyte.com
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