Kadmon to Present 12-Month Data from Pivotal Trial of Belumosudil for cGVHD at the 62nd ASH Annual Meeting
NEW YORK, NY / ACCESSWIRE / November 4, 2020 / Kadmon Holdings, Inc. (NASDAQ:KDMN) announced today that 12-month data from ROCKstar (KD025-213), the ongoing pivotal trial of belumosudil (KD025) for the treatment of chronic graft-versus-host disease (cGVHD), have been selected for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually December 5 - 8, 2020.
The presentation will include 12-month efficacy and safety data and key secondary endpoints including duration of response, Failure-Free Survival, steroid dose reductions and quality-of-life improvements.
As previously announced, belumosudil met the primary endpoint of ROCKstar, the fully enrolled pivotal trial in cGVHD patients who have received at least two prior lines of systemic therapy. On September 30, 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for belumosudil for the treatment of patients with cGVHD.
Details of the presentation are as follows:
ROCKstar (KD025-213) Oral Presentation
Title: Belumosudil for Chronic Graft-Versus-Host Disease (cGVHD) after 2 or More Prior Lines of Therapy: The ROCKstar Study (KD025-213)
Presenter: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune
Date & Time: Sunday, December 6, 2020, 9:30am - 11:00am PT
Abstract #: 353
The accepted abstract is now available online at www.hematology.org. The oral presentation will include updated data not available in the abstract.
ROCKstar (KD025-213) is an ongoing open-label trial of belumosudil in patients with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive belumosudil 200 mg once daily or 200 mg twice daily, enrolling 66 patients per arm. The primary endpoint of the study is Overall Response Rate (ORR). The ORR endpoint was met at the interim analysis, conducted two months after completion of enrollment. At the study's primary analysis, conducted six months after completion of enrollment, belumosudil achieved ORRs of 73% and 74% in the respective arms. Belumosudil has been well tolerated and adverse events have been consistent with those expected in the patient population.
Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. Kadmon has submitted an NDA to the U.S. FDA for belumosudil for the treatment of patients with cGVHD and the NDA is being reviewed under the FDA's RTOR pilot program. The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD after failure of two or more lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD.
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD.
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Our clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.
Forward Looking Statements
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Ellen Cavaleri, Investor Relations
SOURCE: Kadmon Holdings, Inc.
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