BioCentury
ARTICLE | Clinical News

Incyte's Jakafi meets in Phase II for steroid-refractory GvHD

July 13, 2018 7:22 PM UTC

Incyte Corp. (NASDAQ:INCY) said Jakafi ruxolitinib in combination with corticosteroids met the primary endpoint in the U.S. Phase II REACH1 trial to treat steroid-refractory acute graft-versus-host disease (GvHD). The company plans to submit an sNDA to FDA for Jakafi in the indication this quarter. The drug is an oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor.

In the open-label trial, twice-daily Jakafi plus IV prednisone or methylprednisolone led to an overall response rate (ORR) of 55% at day 28 among 71 patients. The best ORR was 73%...