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Spanish Real-World Experience with Belumosudil for Chronic Graft-versus-Host Disease after 2 or More Prior Lines of Therapy

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Bailén R.
  • Peña-Muñoz F.
  • Bermúdez A.
  • López-Corral L.
  • Fox L.
  • de Miguel C.
  • Martín-González J.
  • Pascual-Cascón M.J.
  • Chinea A.
  • González-Sierra P.
  • Izquierdo I.
  • Calbacho M.
  • Vázquez J.
  • Ceballos C.
  • Morales-Curbelo A.
  • Sánchez-Salinas A.
  • Zanabili J.
  • Sisinni L.
  • González-Vicent M.
  • Castilla L.
  • Balsalobre P.
  • Kwon M.

Grupos

Abstract

Belumosudil has been approved by the US Food and Drug Administration for the treatment of chronic graft-versus-host disease (cGVHD) after at least 2 prior lines of therapy. We conducted a retrospective study across 20 centers within the Spanish Group of HSCT and Cell Therapy (GETH-TC), including 86 patients with cGVHD who received belumosudil between July 2022 and December 2024. The patients started belumosudil at a median of 3 years from cGVHD diagnosis, after receiving a median of 4 lines of therapy for cGVHD (range, 2 to 13), which included steroids in 82 patients (95%), ruxolitinib in 77 (90%), and extracorporeal photopheresis in 56 (65%). At belumosudil initiation, cGVHD grade was severe in 78 patients (91%). At a median follow-up of 9 months in surviving patients, 17 patients (20%) had discontinued treatment, 47% because of cGVHD progression or lack of efficacy and 24% due to suspected adverse events. Twenty four percent of patients experienced infections. No deaths have been attributed to belumosudil. Seventy-two patients (84%) who had a minimum follow-up of 3 months were evaluable for response. The overall response rate was 64%, with 7% of patients achieving complete response and 57% achieving partial response. Complete responses were obtained in all organs. The median time to response was 3 months, and the median duration of response was 12.8 months. The median failure-free survival was 18.9 months. Thirty-eight percent of patients achieved discontinuation of concomitant immunosuppression (35% for steroids). Overall survival was 91% at 9 months. Our real-world experience involving heavily pretreated patients with predominantly severe cGVHD confirms the safety and efficacy profile of belumosudil. © 2026 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.

Datos de la publicación

ISSN/ISSNe:
2666-6375, 2666-6367

Transplantation and Cellular Therapy  ELSEVIER SCIENCE INC

Tipo:
Article
Páginas:
8641-86412
PubMed:
41794065
Enlace a otro recurso:
www.scopus.com

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Keywords

  • Acetamides; Adolescent; Adult; Aged; Chronic Disease; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Male; Middle Aged; Pyrazoles; Retrospective Studies; Treatment Outcome; Young Adult; acetamide derivative; belumosudil; pyrazole derivative; adolescent; adult; adverse event; aged; chronic disease; clinical trial; drug therapy; female; graft versus host reaction; hematopoietic stem cell transplantation; human; male; middle aged; multicenter study; retrospective study; treatment outcome; young adult

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