Ruxolitinib improves response, failure-free survival in chronic GVHD
A randomized phase 3 study designed to evaluate ruxolitinib for chronic graft-versus-host disease met its primary and key secondary endpoints.
Topline results of the REACH3 study showed ruxolitinib (Jakafi, Incyte) induced a higher overall response rate at week 24 than best available therapy among patients with steroid-refractory or steroid-dependent chronic GVHD who underwent allogeneic stem cell transplantation.
Ruxolitinib-treated patients also achieved significantly longer failure-free survival, and results showed fewer patient-reported symptoms as determined by a validated chronic GVHD-specific score.
“These positive results from the REACH3 study are significant as they underscore the potential for Jakafi to provide a meaningful treatment option, not only for patients with acute GVHD, but also for the chronic form of the condition,” Peter Langmuir, MD, group vice president for oncology targeted therapies at Incyte, said in a company-issued press release. “Based on the outcome of this phase 3 study, we will move forward with the submission of these data to the [FDA] for this indication, which is a critical step as we work to bring this important therapeutic option to additional patients suffering from GVHD in the U.S.”
Ruxolitinib is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. The FDA approved the agent last year for treatment of patients aged 12 years and older with steroid-refractory acute GVHD. The therapy also is approved in the U.S. for treatment of certain patients with polycythemia vera or myelofibrosis.
The open-label, multicenter REACH3 study compared the efficacy and safety of ruxolitinib with best available therapy for patients with steroid-refractory chronic GVHD.
ORR at day 1 of cycle 7 — or day 168 of treatment — served as the primary endpoint. Secondary endpoints included change in modified Lee chronic GVHD symptom scale score at day 168, failure free survival rate at up to 36 months, best overall response, duration of response and OS.
Complete data from the study will be presented at a major medical congress, according to the press release.