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Hematopoietic stem cell transplantation is a common treatment for blood or bone marrow cancer.
, however, in patients with cGVHD, transplanted immune cells attack the host's healthy cells, with a range of serious side effects.
estimated that about 30 to 70 percent of patients receiving hematopoietic stem cell transplants develop cGVHD symptoms, including inflammatory reactions and fibrosis of multi-organ tissue.
As a ROCK2 kinase inhibitor, belumosudil can enhance the phosphorylation of STAT5 by reducing phosphorylation of STAT3, thereby reducing over-active T-assisted cells (Th17) and enhancing the function of regulated T-cells (Treg) to rebuild immune balance.
the FDA previously awarded belumosudil breakthrough therapy and orphan drug qualifications for the treatment of cGVHD patients.
mechanism of effects of rock2 inhibitors (Photo source: Resources) The submission of NDA was supported by positive data from ROCKstar (KD025-213), a critical study in which patients with cGVHD who had received at least 2 systemic treatments were involved and were randomly grouped into different doses of belumosudil.
preliminary analysis of the trial showed that the objective remission rate (ORR) was 73% for patients treated once a day for 200 mg belumosudil, compared with 74% for patients treated twice a day for 200 mg belumosudil.
, 49 percent of patients who received remission had sustained significant remission for at least 20 weeks during the initial analysis.
12-month data from roCKstar will be presented at the upcoming 62nd annual meeting of the American Society of Hematology (ASH).
: s1. Kadmon Announces FDA Acceptance of NDA for Belumosudil in Patients With Chronic Graft-Versus-Host Disease. Retrieved November 30, 2020, from [2] KD025-208: A Phase 2a Study of KD025 for Patients with Chronic Graft Versus Host Disease (cGVHD): Pharmacodynamics and Updated Results. Retrieved 2020-05-21, from ~/media/Files/K/Kadmon-IR/event-presentations/KD025208-tct-mtg-2-1-19.pdf。
