Incyte: REACH1 Pivotal Trial With Ruxolitinib Meets Primary Endpoint

(RTTNews) - Incyte Corp. (INCY) reported positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease. The company said the study met its primary endpoint, demonstrating an overall response rate of 55 percent at day 28. The number of patients achieving a response at any time point during the study, was 73 percent. The most common treatment-emergent adverse events of any grade were anemia, thrombocytopenia and neutropenia.

Based on the data from REACH1, Incyte plans to file a Supplemental New Drug Application (sNDA) for the approval of ruxolitinib for the treatment of steroid-refractory acute graft-versus-host disease with the U.S. FDA during the third quarter of 2018.