In late July of this year, biopharmaceutical company, Incyte, announced that the very first treatment in a Phase 3 clinical trial for itacitinib had been administered for an acute graft-versus-host disease (GvHD) patient.
Itacitinib is a Janus kinase inhibitor 1 (JAK1) treatment option, and it is to be used alongside corticosteroids as a first-line treatment option for acute graft-versus-host disease (GvHD).
Graft-versus-host disease (GvHD) is a rare complication in which transplanted cells attack the recipient’s body after a stem cell or bone marrow transplantation.
As of right now, immunosuppressant drugs and/or corticosteroids are the common treatments for GvHD, and they are usually successful. However, the condition may relapse, so a stronger therapy option is needed.
That’s what this new Phase 3 study is for. Known as GRAVITAS-301, this study will enroll about 430 patients who have gone through any kind of donor source for a “hematologic malignancy” or disorder, such as non-Hodgkin lymphomas or multiple myeloma.
The hope is to for participants in the trial to have an overall response rate at the 28th day, in which subjects demonstrate a complete, very good, or partial response to the drug (the primary endpoint). Further, a key additional endpoint for the trial includes nonrelapse mortality in the first six months.
The last date for data collection in this study is April of 2019, with final completion scheduled for March of 2020.