The Reach3 trial (NCT03112603) is a randomized, multicenter phase III trial designed to compare the efficacy and safety of ruxolitinib in patients with chronic graft-versus-host disease (cGvHD) with the best available therapy—a study overview can be found here. Ruxolitinib is a first-in-class oral inhibitor of the tyrosine kinases JAK1 and JAK2 that has been approved for the treatment of polycythemia vera and myelofibrosis in adults, and acute GvHD in adults and pediatric patients ≥ 12 years of age.1
The Reach3 trial compared ruxolitinib with standard cGVHD therapies, and topline results show that the ruxolitinib treatment arm met the primary endpoint, which was to improve the overall response rate at 24 weeks for patients with steroid-refractory or steroid-dependent cGvHD who underwent allogeneic stem cell transplantation.
The trial also met key secondary endpoints, significantly improving failure-free survival and patient-reported symptoms as measured by the modified Lee cGvHD symptom scale.
The Reach3 study builds on the results of the Reach1 and Reach2 trials, which demonstrated that ruxolitinib was effective at improving outcomes in patients with steroid-refractory acute GvHD. The results of the Reach2 trial were recently reported by the GvHD Hub.
The Reach3 trial results will form the basis of a submission to the U.S. Food and Drug Administration (FDA) for the approval of ruxolitinib in patients with steroid-refractory or steroid-dependent cGvHD.1
The complete results of the study will be presented at the 46th European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting, which will be held as a virtual edition on August 28–September 1, 2020.