A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

Summary

The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).

Timeline

Start

2016-12-30

Primary completion

2018-01-31

Completion

2019-08-14

Outcome

Met primary endpoint

release “Pivotal REACH1 study of Jakafi® (ruxolitinib) in steroid-refractory acute GVHD met primary endpoint; sNDA submission expected in the third quarter of 2018” incyte.com ↗

release “The study met its primary endpoint, demonstrating an overall response rate (ORR) of 55 percent (n=39/71) at Day 28.” incyte.com ↗

release “As previously announced, the study met its primary endpoint, demonstrating an overall response rate (ORR) of 55 percent (n=39/71) at Day 28” incyte.com ↗

Publications

• Jagasia M, Perales MA, Schroeder MA, Ali H, Shah NN, Chen YB, Fazal S, Dawkins FW, Arbushites MC, Tian C, Connelly-Smith L, Howell MD, Khoury HJ. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14;135(20):1739-1749. doi: 10.1182/blood.2020004823.
• Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	10 mg	Oral
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Prednisone	Other / unclassified	—	Oral

Indications