Phase III REACH3 study of Jakafi meets primary endpoint in chronic graft-versus-host disease.- Incyte

Incyte announced that the Phase III REACH3 study evaluating Jakafi (ruxolitinib) in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint of superior overall response rate (ORR) at Week 24 compared to best available therapy (BAT).

In addition, the study also met both key secondary endpoints, significantly improving failure-free survival (FFS) and patient-reported symptoms assessed by the modified Lee chronic GVHD symptom scale (mLSS). These topline results build on previously-reported positive data from the REACH1 and REACH2 trials, which demonstrated that Jakafi improved outcomes across a range of efficacy measures in patients with steroid-refractory acute GVHD.

Data from the REACH3 study are expected to be presented at an upcoming major medical congress and will also be prepared for submission to the FDA seeking approval in patients with steroid-refractory or steroid dependent GVHD.