- ORRs of 73% and 77% with Belumosudil 200 mg QD and 200 mg BID, Respectively -
- cGVHD Key Opinion Leader Webcast Today at
At the 12-month follow-up analysis, belumosudil achieved clinically meaningful and statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily (QD) (95% Confidence Interval (CI): 60%, 83%; p<0.0001) and 77% with 200 mg twice daily (BID) (95% CI: 65%, 87%; p<0.0001) in patients with cGVHD who have received at least two prior lines of systemic therapy. Responses were achieved across key patient subgroups and complete responses were observed in all organ systems, including in lung.
Belumosudil performed well across all secondary endpoints:
- Responses were durable, with a median duration of response of 50 weeks; 60% of responders have maintained their responses for 20 weeks or longer
- A Failure-Free Survival (FFS) rate of 58% was maintained at 12 months
- Clinically meaningful improvement from baseline in the Lee Symptom Scale (LSS) score, a quality-of-life measurement, was observed in 60% of patients
- 64% of patients were able to reduce their corticosteroid dose, with 21% of patients completely discontinuing corticosteroid therapy
- Belumosudil has been well tolerated and adverse events have been consistent with those expected in the cGVHD patient population
"The positive results achieved with belumosudil have continually demonstrated its ability to meaningfully address the broad spectrum of cGVHD manifestations, including difficult-to-treat organs like lung," said
"We are extremely pleased with the 12-month results from this trial, as the Overall Response Rates have consistently strengthened, the durability has proven to be robust, the drug continues to perform across a number of key secondary endpoints and has been well tolerated," said
Key Opinion Leader Event Details
Kadmon will host a key opinion leader event on
The event will be archived and will be available at https://investors.kadmon.com/presentations-and-events. Replays of the event will be available for 60 days.
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 follow-up analysis, conducted twelve months after completion of enrollment, belumosudil achieved ORRs of 73% and 77% 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. In
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
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.
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