A phase 3 study of ruxolitinib (Jakafi) has met its primary end point of superior overall response rate (ORR) compared with the best available therapy in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD).
A phase 3 study of ruxolitinib (Jakafi) has met its primary end point of superior overall response rate (ORR) compared with the best available therapy (BAT) in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD).
Ruxolitinib is a Janus kinase (JAK) 1/JAK2 inhibitor that is already approved by the FDA to treat polycythemia vera in adults, intermediate or high-risk myelofibrosis in adults, and steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
The results were from the phase 3 REACH3 trial, which builds on data from the REACH1 and REACH2 trials. The previous trials showed that ruxolitinib improved outcomes in patients with steroid-refractory acute GVHD. In REACH2, patients treated with ruxolitinib had an ORR of 62% compared with 39% for those treated with BAT. Median failure-free survival in REACH2 as 5.0 months for patients treated with ruxolitinib compared with 1.0 months for patients on BAT.
Full results from REACH3 are expected to be presented in the future at a major medical congress. In addition, the results will be prepared as part of a submission to the FDA for approval of ruxolitinib in patients with steroid-refractory or steroid dependent GVHD.
REACH3 also met secondary end points of improving failure-free survival and patient-reported symptoms assessed by the modified Lee Chronic GVHD Symptom Scale. The trial was a randomized, open-label multicenter phase 3 study.
“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, oncology targeted therapies, Incyte, said in a statement.