Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial
- Author(s)
- Mohty, M; Socié, G; Szer, J; Niederwieser, D; Butler, J; Wagner-Drouet, E; Or, R; Rovenvald-Zuckerman, T; Bozdag, SC; Forcade, E; Grillo, G; Kröger, N; Stölzel, F; Russo, D; Sanz, J; Sarkar, R; Stefanelli, T; Wilke, C; Zeiser, R; von Bubnoff, N;
- Journal Title
- Journal of Clinical Oncology
- Publication Type
- Online publication before print
- Abstract
- Approximately 30%-50% of patients develop acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (Allo-HCT), representing a major limitation of this treatment. Although corticosteroids remain the standard first-line therapy for aGVHD, up to 50% of patients become steroid-refractory (SR). REACH2 is a phase III study of ruxolitinib versus best available therapy (BAT) in patients age 12 years and older with SR-aGVHD after Allo-HCT. We present the final efficacy and safety outcomes from REACH2 after 24 months of treatment. Cumulative median (range) duration of response was 167 (22-677) days with ruxolitinib and 106 (10-526) days with BAT. Median overall survival and event-free survival were 10.7 and 8.3 months for ruxolitinib, compared with 5.8 and 4.2 months, respectively, with BAT. Median failure-free survival was significantly longer with ruxolitinib than with BAT (4.86 v 1.02 months, P < .001). Similar numbers of nonrelapse mortality events were observed with ruxolitinib and BAT (72 v 71), and malignancy relapse/progression events remained low across both groups. Numerically higher chronic GVHD rates were noted with ruxolitinib than with BAT from 12 months; however, 95% confidence intervals overlapped. Safety observations were consistent with the primary analysis results. Ruxolitinib provided efficacy advantages over BAT in patients with SR-aGVHD over 24 months.
- Department(s)
- Haematology
- Publisher's Version
- https://doi.org/10.1200/jco-25-00809
- Open Access at Publisher's Site
https://doi.org/10.1200/jco-25-00809- Terms of Use/Rights Notice
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Creation Date: 2025-11-13 02:49:18
Last Modified: 2025-11-13 02:49:45