Kadmon (KDMN) Announces Publication of Phase 2a Clinical Trial Results of Belumosudil for cGVHD in the Journal of Clinical Oncology

April 21, 2021 8:01 AM EDT

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Kadmon Holdings, Inc. (NASDAQ: KDMN) today announced the publication of results from KD025-208, the Phase 2a clinical trial of belumosudil (KD025) for chronic graft-versus-host disease (cGVHD). The results were published in the Journal of Clinical Oncology. A New Drug Application (NDA) for belumosudil is currently under Priority Review by the U.S Food and Drug Administration (FDA) for the treatment of patients with cGVHD, with a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2021.

"The results from our first clinical study in cGVHD demonstrated that belumosudil achieves meaningful, long-lasting responses and is very well tolerated in refractory cGVHD patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "These positive results were replicated in the ROCKstar pivotal trial and support belumosudil's ability to offer meaningful clinical benefit, if approved, to patients with cGVHD, for which new therapies are urgently needed."

Results from KD025-208, the open-label, Phase 2a clinical trial of belumosudil, which enrolled 54 cGVHD patients who had received one to three prior lines of therapy, demonstrated a pooled Overall Response Rate (ORR) of 65% across the three patient cohorts. Responses were achieved across patient subgroups, including in patients with four or more organs involved. Responses were durable, with a median duration of 35 weeks in responders. In addition, 50% of responders experienced a clinically meaningful improvement in symptoms, as measured by at least a 7-point decrease in the Lee cGVHD Symptom Scale score. Belumosudil was also shown to be steroid sparing: 67% of all patients were able to reduce steroid doses and 19% of patients completely discontinued steroids. Belumosudil was well tolerated across all cohorts, with no drug-related serious adverse events and no increased risk of infection observed.

The publication, titled "ROCK2 Inhibition with Belumosudil (KD025) for the Treatment of Chronic Graft-Versus-Host Disease," is available online here as well as on the Kadmon website.



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