Incyte Corporation has announced that the first patient has been treated in GRAVITAS-309, a pivotal Phase 3 trial for the first-line treatment of patients with chronic graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel and selective JAK1 inhibitor, in combination with corticosteroids.
“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 Steven Stein, M.D., chief medical officer at Incyte.
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 tract and liver.
It is estimated that there are approximately 15,000 new cases of GVHD diagnosed each year in the U.S., Europe and Japan, where approximately 12,000 new cases are acute GVHD and 3,000 de novo cases are chronic GVHD. 1,2 The prevalence of chronic GVHD in the U.S., Europe and Japan is estimated to be approximately 25,000 patients. 3
A Phase 3 study (GRAVITAS-301) of itacitinib for the treatment of patients with acute GVHD is already underway, with results expected in 2019.