Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial
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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (20)
Mohamad Mohty
Gerard Socie
Hematology Transplantation, Assistance Publique–Hôpitaux de Paris, Hospital Saint Louis, Paris, France
Jeff Szer
5Peter MacCallum Cancer Centre, The Royal Melbourne Hospital, Melbourne, Australia
Dietger Niederwieser
2University of Pennsylvania & Penn Medicine, Pennsylvania, United States
Jason Butler
1University of Florida, Medicine, Gainesville, United States
Eva Wagner-Drouet
Department of Hematology and Oncology, University Medical Center Mainz, Mainz, Germany
Reuven Or
Cancer Immunotherapy Research Center, Hadassah University Medical Center, Jerusalem, Israel
Tsila Rovenvald-Zuckerman
Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Rappaport Faculty of Medicine, Technion, Haifa, Israel
Sinem Civriz Bozdag
Ankara University Medical Faculty, Ankara, Turkey
Edouard Forcade
Giovanni Grillo
17Dipartimento di Ematologia e Trapianto di midollo, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
Nicolaus Kröger
From the Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Friedrich Stölzel
8Department of Internal Medicine II, Hematology and Oncology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany
Domenico Russo
Institute of Endotypes in Oncology, Metabolism and Immunology “G. Salvatore,” National Research Council of Italy
Jaime Sanz
2Hospital Universitari i Politècnic La Fe, Valencia Departament de Medicina Universitat de Valencia, CIBERONC, Instituto Carlos III, Madrid, Spain, Hematology Department, Valencia, Spain
Rajendra Sarkar
Novartis Healthcare Pvt Ltd, Hyderabad, India
Tommaso Stefanelli
Novartis Pharma, Basel, Switzerland
Celine Wilke
Novartis Pharma, Basel, Switzerland
Robert Zeiser
Nikolas von Bubnoff