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Unmet Need

cGVHD has a high unmet need beyond 2L, as current treatments inadequately address diverse manifestations such as fibrosis and do not support long-term use, resulting in rapid disease progression.1

Guidelines clearly state that there are no standard therapies for SR patients1,2,4,6, limiting these patients to the following available therapies:

Currently, there is no consensus on the optimal choice of agents for 3L or further lines of therapy as per the major guidelines1

The need to investigate novel therapies to address the fibrotic manifestations of cGVHD in 2L and 3L has been recognized7, 10

cGVHD progression is a key reason to modify or discontinue cGVHD therapy7

1L

2L

3L
3 to 7 months 3 to 4 months 4 to 5 months
96%7 71%7 47%7

Abbreviations

1L: First Line; 2L: Second Line; 3L: Third Line; SR: Steroid-resistant; NCCN : National Comprehensive Cancer Network; ASH: American Society of Hematology; ANZTCT: Australia and New Zealand Transplant & Cellular Therapies; EBMT: European Society for Blood and Marrow Transplantation; ECP: Extracorporeal photopheresis; cGVHD: Chronic graft-versus-host disease.

  1. Hamilton, B.K., et al., "Updates in Chronic Graft-versus-Host Disease." Hematology Am Soc Hematol Educ Program. 2021 Dec 10; 2021(1): 648-654. doi: 10.1182/hematology.2021000301
  2. Loren, A.W., et al., "Hematopoietic Cell Transplantation, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology (August 2024)
  3. Amanam, I., et al., « Chronic GVHD: review advances in prevention, novel endpoints, and targeted strategies. Hematology Am Soc Hematol Educ Program 2023; 2023 (1): 164–170. doi: https://doi.org/10.1182/hematology.2023000427
  4. EviQ Clinical Resource on Chronic GVHD. Available at: https://www.eviq.org.au/clinical-resources/3829-chronic-graft-versus-host-disease-cgvhd#treatment, 2024 3829-Chronic graft versus host disease (cGVHD) | eviQ (Last Reviewed: 23 October 2024)
  5. Hamad, Nada, et al. "ANZTCT consensus position statement on ruxolitinib in steroid‐refractory acute and chronic graft‐versus‐host disease." Internal Medicine Journal 53.12 (2023): 2319-2329.
  6. Penack, O., et al., “Prophylaxis and management of graft-versus-host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation”, The Lancet Haematology, Volume 11, Issue 2, 2024, Pages e147-e159, ISSN 2352-3026, https://doi.org/10.1016/S2352-3026(23)00342-3;
  7. Gonzalez RM, Pidala J. Evolving therapeutic options for chronic graft vs. host disease [published online ahead of print May 22 2020]. Pharmacotherapy. doi: 10.1002/phar.2427.
  8. Bachier et al. Epidemiology and Treatment of Chronic Graft-versus-Host Disease Post-Allogeneic Hematopoietic Cell Transplantation: A US Claims Analysis. Transplant Cell Ther. 2021 Jun;27(6):504.e1-504.e6. doi: 10.1016/j.jtct.2020.12.027.
  9. EU5 cGVHD patient pathway and treatment algorithm 2020. Sanofi internal analysis and Adelphi DSP, 1Q2020.
  10. Akpek, G., Zahurak, M.L., Piantadosi, S., Margolis, J., Doherty, J., Davidson, R. & Vogelsang, G.B. (2001a) Development of a prognostic model for grading chronic graft-versus-host disease. Blood, 97, 1219–1226.
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