Incyte says REACH1 trial met primary endpoint of ORR for Ruxolitinib
Incyte (INCY) announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib, or Jakafi, in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease.
The study met its primary endpoint, demonstrating an overall response rate of 55% at Day 28.
In addition, the best overall response rate , the number of patients achieving a response at any time point during the study, was 73%.
The most common treatment-emergent adverse events of any grade were anemia, thrombocytopenia and neutropenia.
Based on these data from REACH1, Incyte plans to file a Supplemental New Drug Application for the approval of ruxolitinib for the treatment of steroid-refractory acute GVHD with the U.S. FDA during the third quarter of 2018.
“The results of the REACH1 study demonstrate the potential of ruxolitinib to meaningfully improve the outcomes of allogeneic transplant patients who develop steroid-refractory acute GVHD and further underscore the promise of JAK inhibition to advance the treatment of this potentially-devastating condition,” said Steven Stein, M.D., Chief Medical Officer, Incyte.
“We look forward to sharing additional results from this study with the medical community, and to working with U.S. regulatory authorities to submit our supplementary new drug application seeking approval of ruxolitinib in this indication later this year.”
INCY closed at $73.43, it last traded at $74.65.
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