NEW YORK, NY / ACCESSWIRE / January 10, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that expanded data from the interim analysis of ROCKstar (KD025-213), its ongoing pivotal trial of KD025 in chronic graft-versus-host disease (cGVHD), will be presented in a late-breaking oral presentation at the 2020 Transplantation & Cellular Therapy (TCT) Meetings to be held February 19-23, 2020 in Orlando, FL. The expanded dataset will include response rates across key subgroups and initial safety data for ROCKstar, which is evaluating KD025 in cGVHD in patients who had received at least two prior lines of systemic therapy.
In November 2019, Kadmon announced that KD025 met the primary endpoint at the planned interim analysis of ROCKstar, which was conducted as scheduled two months after completion of enrollment. At the interim analysis, KD025 showed clinically and statistically significant Overall Response Rates (ORRs) of 64% with KD025 200 mg once daily and 67% with KD025 200 mg twice daily.
At TCT 2020, Kadmon will also present long-term follow-up data from KD025-208, its ongoing Phase 2 study of KD025 in chronic graft-versus-host disease (cGVHD). These data were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in December 2019.
The abstracts are expected to be made available online via the TCT website in the coming weeks. Details of the presentations are as follows:
KD025-213 Oral Presentation
Title: Interim Analysis of KD025-213: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) after at Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study; NCT03640481)
Presenter: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Session Title: Late Breaking Abstracts
Session Date and Time: Sunday, February 23, 2020, 12:00 p.m. ET
Location: Marriott World Center, Orlando, FL
Abstract ID: LBA2
KD025-208 Poster Presentation
Title: KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD) - Long-Term Follow-up of a Phase 2a Study (KD025-208)
Presenter: Daniel Weisdorf, MD, Clinical and Translational Science Institute, University of Minnesota
Session Title: Graft-Versus-Host and Graft-Versus-Tumor - Clinical: Prevention, Treatment and Biomarkers
Session Date and Time: Wednesday, February 19, 2020, 6:30 - 8:00 p.m. ET
Location: Marriott World Center, Orlando, FL
Abstract ID: #15205
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.