Press release
Incyte Announces that the REACH2 Pivotal Trial of Ruxolitinib (Jakafi®) Meets Primary Endpoint in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease
- Results of randomized Phase 3 REACH2 trial show that ruxolitinib significantly improves overall response rate (ORR) at 28 days vs. best available therapy
About this update from Incyte Corporation
[{"type":"text","content":"\n- Results of randomized Phase 3 REACH2 trial show that ruxolitinib significantly improves overall response rate (ORR) at 28 days vs. best available therapy in patients with steroid-refractory acute graft-versus-host disease (GvHD)\n\n\n- Full results expected to be submitted to an upcoming scientific meeting\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte Corporation (Nasdaq:INCY) today announced positive results from the Novartis-sponsored pivotal Phase 3 REACH2 study evaluating ruxolitinib (Jakafi®) in patients with steroid-refractory acute graft-versus-host disease (GVHD). The study met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy. No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported studies in steroid-refractory acute GVHD.\n\n\nFurther analysis of the safety and efficacy data is ongoing. Novartis expects to initiate discussions with ex-U.S. regulatory authorities in 2020, and to submit REACH2 results for presentation at an upcoming scientific meeting.\n\n\n“GVHD is a challenging and serious disease, and physicians around the world need access to therapies that can improve outcomes for patients,” said Peter Langmuir, M.D., Group Vice President, Targeted Therapies, Incyte. “This positive result of the REACH2 study is excellent news for patients as it further reinforces the potential of ruxolitinib as a treatment option that can provide meaningful results for patients with steroid-refractory acute GVHD.”\n\n\nGVHD is a condition that can occur after an allogeneic transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD, acute and chronic, that can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.\n\n\nEarlier this year, Jakafi was approved by the U.S. Food and Drug Administration (FDA) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older based on results of the REACH1 trial. Jakafi is marketed by Incyte in the U.S.; ruxolitinib (Jakavi®) is licensed to Novartis ex-U.S.\n\n\nIn addition, the ...