A pooled analysis of Sanofi’s Rezurock (belumosudil), for the treatment of chronic graft-versus-host disease (cGVHD), has shown that certain organ clinical responses have correlated with clinically meaningful changes in patient-reported outcomes (PROs).
The condition is a complication that can often occur following allogeneic stem cell transplantation, resulting in both significant morbidity and mortality among patients. In cGVHD, transplanted immune cells typically attack the patient’s cells, leading to inflammation and fibrosis in a number of tissues.
Results from the ROCKstar and KD025-208 studies showed particularly significant changes across the regions of the skin, mouth, eyes, upper gastrointestinal area and lungs – clearly showing the potential to increase the quality of life for many thousands of cGVHD patients worldwide.
Following the studies, the data also supports the use of PROs for response assessment in cGVHD clinical trials and patient care in order to help capture the pivotal individual perspectives on disease activity. There are approximately 14,000 patients living with cGVHD in the US.
Rezurock is the first and, currently, only approved therapy inhibiting rho-associated coiled-coil kinase 2 (ROCK2). The therapy is approved in the US for the treatment of adult and paediatric cGVHD patients aged 12 years and over. This group would also have had at least two failures with prior lines of systemic therapy.
Jonathan Ieyoub, head of Sanofi US Rezurock Medical, was optimistic about the results and, especially how patients contributed, saying: “This Rezurock data reinforces the importance of patient-reported outcome measures by showing their correlation to clinical response.”
“Knowing the impact that chronic graft-versus-host disease has on patients, the results add support for use of patient-reported outcomes to assess responses in clinical care,” he added.
Kadmon – a Sanofi Company – is due to present the results at the 2022 American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research Tandem Meetings.