Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial
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 <i>v</i> 1.02 months, <i>P</i> < .001). Similar numbers of nonrelapse mortality events were observed with ruxolitinib and BAT (72 <i>v</i> 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.
Authors
- Jason Butler (ORCID: https://orcid.org/0000-0002-6422-4404)
- Gèrard Socié (ORCID: https://orcid.org/0000-0002-2114-7533)
- Mohamad Mohty (ORCID: https://orcid.org/0000-0002-7264-808X)
- Reuven Or
- Jeff Szer (ORCID: https://orcid.org/0000-0001-6783-2301)
- Eva Wagner-Drouet (ORCID: https://orcid.org/0000-0002-0728-2253)
- Giovanni Grillo (ORCID: https://orcid.org/0000-0002-9084-9969)
- Domenico Russo (ORCID: https://orcid.org/0000-0003-4458-6261)
- Jaime Sanz (ORCID: https://orcid.org/0000-0001-6934-4619)
- Dietger Niederwieser (ORCID: https://orcid.org/0000-0002-4737-1103)
- Sinem Civriz Bozdağ (ORCID: https://orcid.org/0000-0001-8359-7794)
- Friedrich Stölzel (ORCID: https://orcid.org/0000-0003-0653-5332)
- Rajendra Sarkar
- Robert Zeiser (ORCID: https://orcid.org/0000-0001-6565-3393)
- Édouard Forcade (ORCID: https://orcid.org/0000-0002-8873-2868)
- Tommaso Stefanelli
- Nicolaus Kröger
- Celine Wilke
- Tsila Rovenvald-Zuckerman
Institutions
- Novartis (Switzerland) (CH)
- Ankara University (TR)
- Inserm (FR)
- Universität Hamburg (DE)
- University of Freiburg (DE)
- Johannes Gutenberg University Mainz (DE)
- Royal Brisbane and Women's Hospital (AU)
- Hadassah Medical Center (IL)
- Peter MacCallum Cancer Centre (AU)
- University Medical Center Freiburg (DE)
- Rambam Health Care Campus (IL)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Hospital Universitari i Politècnic La Fe (ES)
- Sorbonne Université (FR)
- Novartis (India) (IN)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
- Assistance Publique – Hôpitaux de Paris (FR)
- Hôpital Saint-Antoine (FR)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- University Medical Center Hamburg-Eppendorf (DE)
- University Hospital Schleswig-Holstein (DE)
- Penn Center for AIDS Research (US)
- Centre de Recherche Saint-Antoine (FR)
- Hôpital Saint-Louis (FR)
- Technische Universität Dresden (DE)
- University of Brescia (IT)
- University of Lübeck (DE)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2025-10-15
- DOI
- https://doi.org/10.1200/jco-25-00809
- Primary Topic
- Hematopoietic Stem Cell Transplantation
- Type
- article
- Field-Weighted Citation Impact
- 0.00