Incyte Says Phase 3 REACH2 Trial Meets Endpoint
October 16 2019 - 8:06AM
Dow Jones News
By Michael Dabaie
Incyte Corp. (INCY) said the Novartis (NVS)-sponsored REACH2
pivotal trial of ruxolitinib, or Jakafi, met its primary endpoint
in patients with steroid-refractory acute graft-versus-host
disease.
The Novartis-sponsored pivotal Phase 3 REACH2 study met its
primary endpoint of improving overall response rate at Day 28 with
ruxolitinib treatment compared to best available therapy, Incyte
said. 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.
Jakafi is marketed by Incyte in the U.S. and by Novartis as
Jakavi outside the U.S.
Further 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, Incyte said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 16, 2019 07:51 ET (11:51 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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