Kadmon Holdings Inc (NASDAQ: KDMN), in a statement, announced that pivotal trial data from the ROCKstar clinical trial of REZUROCK™ (belumosudil) is published in the journal Blood. In addition, the company was in the news for receiving FDA approval of its REZUROCK™ drug ahead of the deadline. The FDA-approved drug is used to treat patients over 12-years old who are suffering from cGVHD after experiencing failure of at least two prior attempts of systemic therapy.
In a bid to receive an FDA nod for the REZUROCK™ drug, the company initiated the ROCKstar clinical trial. Belumosudil has proved to be very effective on all organs, and it has also proved to be safe and tolerated.
Comments pour in from various quarters
Experts comment on Belumosudil and its impact. “Belumosudil is very effective in inducing responses across all organs affected by cGVHD and is safe and well tolerated. It is exciting to see the development of new interventions that can help patients,” said Corey Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School; Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute and ROCKstar study investigator.
“Leveraging ROCK inhibition to address both the immune and fibrotic components of cGVHD is a welcome step forward in the treatment of this debilitating disease.”
“The results from ROCKstar showcase the benefit that belumosudil can provide to cGVHD patients, including reducing and eliminating corticosteroid and calcineurin inhibitor doses and achieving improvements in quality of life,” said Harlan W. Waksal, M.D., President and CEO of Kadmon. “We are pleased by the recent FDA approval of REZUROCK and look forward to making the drug available to patients in the near term.”
About 132 cGVHD patients were enrolled in ROCKstar
According to reports, as many as 132 cGVHD patients were enrolled in the ROCKstar clinical trial of belumosudil. As part of Phase 2 clinical trial, patients who had received two to five prior lines of therapy were enrolled in the trial. The patients who received 200 mg of the dose once daily showed an Overall Response Rate (ORR) of 74%. The patients who received 200 mg twice daily demonstrated an Overall Response Rate (ORR) of 77%.