Press release
Incyte Announces REACH3 Trial of Ruxolitinib (Jakafi®) in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints
- Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to
About this update from Incyte Corporation
[{"type":"text","content":"\n- Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy\n\n\n- The study also met both key secondary endpoints, significantly improving patient-reported symptoms and failure-free survival\n\n\n- GVHD is a serious and common complication of allogeneic stem cell transplants with no widely approved treatment options for patients who do not respond to steroids\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the Phase 3 REACH3 study evaluating ruxolitinib (Jakafi®) 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).\n\n\nThese 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.\n\n\n“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,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “Based on the outcome of this Phase 3 study, we will move forward with the submission of these data to the U.S. 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.”\n\n\nIn 2019, Jakafi was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, based on the positive results of the Phase 2 REACH1 trial. Jaka...