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Ruxolitinib Reaches 55% Response Rate in Pivotal GVHD Trial

Jason M. Broderick @jasoncology
Published: Friday, Jun 22, 2018

Madan Jagasia, MD, MBBS

Madan Jagasia, MD, MBBS

Ruxolitinib (Jakafi) combined with corticosteroids induced an overall response rate of 55% at day 28 in patients with steroid-refractory acute graft-versus-host disease (GVHD), meeting the primary endpoint of the pivotal phase II REACH1 trial, according to Incyte, the manufacturer of the JAK1/JAK2 inhibitor.

Thirty-nine of 71 patients achieved an objective response at day 28. Additionally, 52 patients had a response at any time point in the study, translating to a best overall response rate of 73%. The most frequently reported treatment-related adverse events across all grades included anemia (61%), thrombocytopenia (61%), and neutropenia (56%).

Incyte noted in a press release that it plans to present the full data from REACH1 at an upcoming medical conference, and also intends to submit a supplemental new drug application to the FDA by the end of September 2018 for ruxolitinib for the treatment of patients with steroid-refractory acute GVHD

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