- Updated data to be presented today at the 60th annual ASH meeting
- REACH1 study formed the basis of sNDA, now under Priority Review by the FDA
Incyte Corporation (Nasdaq:INCY) announces updated results from its pivotal Phase 2 REACH1 study evaluating ruxolitinib (Jakafi®) in combination with corticosteroids as a treatment for patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. As previously announced, the study met its primary endpoint, demonstrating an overall response rate (ORR) of 55 percent (n=39/71) at Day 28, along with a best overall response rate (BORR) – patients achieving a response at any time point during the study – of 73 percent (n=52/71).
Many of the patients (68 percent) had Grade III or Grade IV disease at baseline, illustrative of an at-risk patient population, and responses were observed irrespective of grade or steroid refractory (SR) criteria. Responses to ruxolitinib were rapid and durable; the median time to response was seven days and the median duration of response (DOR) for patients who had a minimum of six months of follow-up was 345 days. Adverse events reported were consistent with the safety profile established in prior ruxolitinib studies, and in patients with SR acute GVHD.
These results are being presented at the American Society of Hematology (ASH) Annual Meeting 2018 in San Diego, California, in an oral session today, Monday, December 3, from 7:00 a.m. PT to 8:30 a.m. PT (Location: Manchester Grand Hyatt, Grand Hall A; Oral Session 722, Abstract #601).
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