Incyte Corp. said its itacitinib failed to meet its main goal in a late-stage study for patients with a complication related to stem cell transplants.
The phase 3 trial, called Gravitas-301, evaluated itacitinib combined with corticosteroids in patients with treatment-naïve acute graft-versus-host disease, or GVHD.
GVHD is an immune condition that occurs in some patients after stem cell transplants — also known as allogeneic transplants — when the donated bone marrow or peripheral blood stem cells see the recipient's body as foreign and attack the body. GVHD is often treated with steroid therapy.
Under the study, the itacitinib combination failed to meet the primary endpoint of improving overall response rate — a measure of the treatment's effect — at day 28 compared to placebo.
There was also no difference observed in non-relapse mortality — or the proportion of patients who died due to causes other than malignancy relapse — in those receiving the itacitinib regimen and those receiving placebo.
Meanwhile, the safety profile observed in the trial was consistent with previous studies of itacitinib.