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    Home > Medical News > Medicines Company News > Sanofi Announces Summary Data from Clinical Trial of New Transplant Drug Rezurock

    Sanofi Announces Summary Data from Clinical Trial of New Transplant Drug Rezurock

    • Last Update: 2022-05-17
    • Source: Internet
    • Author: User
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    Sanofi today announced pooled data from a clinical trial of Rezurock (belumosudil) in chronic graft-versus-host disease (cGVHD)
    .
    Results showed clinical remission in some organs with clinically meaningful changes (improvements) in patient-reported outcomes (PROs)
    .
    Rezurock was developed by Kadmon Holdings and was approved by the US FDA in July 2021
    .
    In September 2021, Sanofi acquired Kadmon for $1.
    9 billion, and Rezurock acquired it
    .
    Notably, Rezurock is the first and only ROCK2 small molecule inhibitor approved by the U.
    S.
    FDA for the treatment of pediatric patients (age ≥12 years) and adults with cGVHD who have failed at least 2 prior systemic therapies patients
    .
    cGVHD is a possible complication after allogeneic stem cell transplantation, and the morbidity and mortality are not optimistic
    .
    In cGVHD, transplanted immune cells (the graft) attack the patient's cells (the host), causing inflammation and fibrosis in multiple tissues including the skin, mouth, eyes, joints, liver, lungs, esophagus, and gastrointestinal tract
    .
    It is estimated that there are approximately 14,000 patients with cGVHD in the United States
    .
    Pooled analyses from the ROCKstar (KD025-213) and KD025-028 studies show a very strong, but not generalized, correlation between organ clinical response measures and clinically meaningful changes in PRO in patients treated with Rezurock
    .
    Specifically, clinically meaningful changes in PRO were reported in skin, oral cavity, eye, upper gastrointestinal tract, lung (clinical spirometry score), and overall measures
    .
    These data support the use of PRO for remission assessment in cGVHD clinical trials and patient care to help capture patient feelings
    .
    A pooled analysis of clinical and PRO data included 170 (91.
    3%) patients enrolled in 2 Rezurock studies (n=132, KD025-213; n=54, KD025-208) who had a baseline PRO assessment, at least One follow-up PRO, at least one response assessment
    .
    Median age was 54.
    5 years, 98 (58%) were male, median 3 prior treatments, 70% had severe cGVHD, median follow-up at data cutoff was 15 months (range 0.
    6- 44 months)
    .
    Organ remission was defined as complete remission (CR) and partial remission (PR)
    .
    The pooled analysis showed organ remission rates: 35% (48/135) in the skin, 68% (84/124) in the joints, 57% (56/99) in the oral cavity, 41% (52/128) in the eye, and 73% in the upper GI tract (19/26), lower gastrointestinal 87% (13/15), pulmonary 23% (14/61); overall response rate was 77% (130/170)
    .
    At least one PRO in all organs (except joints, esophagus, and lower GI tract) was statistically associated with National Institutes of Health (NIH) organ response, p<0.
    05
    .
    NIH clinical pulmonary remission, but not pulmonary remission based on FEV1% change, was associated with pulmonary PRO
    .
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