US-based biopharmaceutical company Incyte has commenced its Phase II REACH-1 pivotal trial of ruxolitinib (Jakafi) combined with corticosteroids to treat steroid-refractory acute graft-versus-host disease (GVHD).
Developed in collaboration with Novartis, Incyte’s ruxolitinib is an orally administered janus kinase (JAK) inhibitor, which triggers decrease in levels of inflammatory cytokines, IL-6 and TNF-α.
It has been approved by the US Food and Drug Administration (FDA) to treat people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also used to treat intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
The Single-cohort Phase II trial is a part of the REACH clinical trial programme intended to test the efficacy of ruxolitinib combined with corticosteroids to treat GVHD.
Incyte chief medical officer Steven Stein said: “We are very pleased to have the first patient treated in the pivotal trial programme for ruxolitinib in GVHD, a severe and often life-threatening condition for which there are currently no approved treatments.
“We look forward to building on the clinical evidence to date for ruxolitinib and working with regulators to help address the urgent needs of these patients.”
The study has enrolled an estimated 70 patients.
It is primarily focused on determining the overall response rate triggered by the combination after 28 days of treatment.
The secondary endpoints of the trial are to determine duration of response, overall response rate at day 14, 56, and 100, non-relapse mortality and safety.