“Given the severity of chronic GVHD, we are pleased to announce the
initiation of treatment for the first patient in the GRAVITAS-309 trial,
as it represents a critical next step in our comprehensive development
program aiming to bring important treatment options to market that
address the significant unmet needs of GVHD patients across the spectrum
of the disease,” said
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipients organs, leading to significant morbidity and mortality. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.
It is estimated that there are approximately 15,000 new cases of GVHD
diagnosed each year in the U.S.,
A Phase 3 study (GRAVITAS-301) of itacitinib for the treatment of patients with acute GVHD is already underway, with results expected in 2019.
GRAVITAS-309 (NCT03584516) 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 chronic graft-versus-host disease (cGVHD). The study
will enroll approximately 266 patients 18 years or older who have
undergone one allogeneic stem cell transplant from any donor and any
donor source for a hematologic malignancy or disorder. The primary
endpoint of the GRAVITAS-309 study is overall response rate (ORR) at
Month 6, defined as the proportion of subjects demonstrating a complete
response (CR) or partial response (PR) per
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, and for the treatment of patients with non-small cell lung cancer in combination with osimertinib, an EGFR inhibitor.
Itacitinib was discovered at
Forward Looking Statements
Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: the Company’s plans and expectations for the GRAVITAS-309
program. 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
1 D'Souza A, Fretham C. Current Uses and Outcomes of
Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, 2017.
Available at: http://www.cibmtr.org.
2 Data on file.
3 Jones C., et.al.
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Michael Booth, DPhil
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