On November 24, 2020 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported that the Company will host a virtual key opinion leader event on Sunday, December 6, 2020 at 11:15 a.m. PT (2:15 p.m. ET) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Kadmon, NOV 24, 2020, View Source [SID1234571670]).
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Following the previously announced oral presentation of 12-month data from ROCKstar (KD025-213), the ongoing pivotal trial of belumosudil (KD025) for the treatment of chronic graft-versus-host disease (cGVHD), Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute, will contextualize the data across the Company’s recent New Drug Application (NDA) filing and discuss how belumosudil may fit into the cGVHD treatment landscape, if approved.
The live webcast of the event will be accessible from the Investors page of Kadmon’s website, investors.kadmon.com. Details of the ASH (Free ASH Whitepaper) oral presentation and related key opinion leader event 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, 9:30 a.m. – 11:00 a.m. PT (12:30 p.m. – 2:00 p.m. ET)
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.
Key Opinion Leader Event Details
The key opinion leader event will take place on Sunday, December 6, 2020 at 2:15 p.m. ET and will feature the presenting author of the ASH (Free ASH Whitepaper) presentation, Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute. The live webcast event may be accessed through the following link:
Title: Kadmon Key Opinion Leader Event
Speaker: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Date & Time: Sunday, December 6, 2020, 11:15 a.m. – 12:00 p.m. PT (2:15 p.m. – 3:00 p.m. ET)
Webcast Link: View Source
Webinar ID: 980 1644 8979
Individuals may participate in an interactive Q&A session by submitting questions via the webcast platform. The live webcast may also be accessed through the Events & Presentations page in the Investors section of the Company’s website at investors.kadmon.com. An archived version of the webcast will be available in the News & Events section of the Investors page of Kadmon’s website for 60 days following the event.
About ROCKstar
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.
About Belumosudil
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 a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for belumosudil for the treatment of patients with cGVHD and the NDA is being reviewed under the FDA’s Real-Time Oncology Review (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.
About 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.