REACH2 pivotal trial of Jakafi meets primary endpoint in GVHD
US biotech Incyte Corp (Nasdaq: INCY) today announced positive results from the Novartis (NOVN: VX)-sponsored pivotal Phase III REACH2 study evaluating Jakafi (ruxolitinib) in patients with steroid-refractory acute graft-versus-host disease (GVHD).
The study met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy. 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.
Further analysis of the safety and efficacy data is ongoing. Novartis expects to initiate discussions with ex-US regulatory authorities in 2020, and to submit REACH2 results for presentation at an upcoming scientific meeting.
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