Belumosudil 200 mg daily achieved an overall response rate of 75% (95% CI, 63-85) through Cycle 7 Day 1 in patients with chronic GvHD after failure of at least two prior lines of systemic therapy.
Cohort (n=65)
Open-label
Does belumosudil improve overall response rate in patients 12 years and older with chronic GvHD after failure of at least two prior lines of systemic therapy?
The FDA approved belumosudil for chronic GvHD after failure of at least two prior lines of systemic therapy based on a 75% overall response rate in a single-arm study.
On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the results of Study KD025-213, which included 65 patients with cGvHD treated with belumosudil 200 mg daily in an open-label, single-arm cohort. Efficacy was determined by the overall response rate (ORR) through Cycle 7 Day 1, which included complete response (CR) or partial response (PR) according to the 2014 NIH consensus criteria, and durability of response. The ORR through Cycle 7 Day 1 was 75% 95% confidence interval (CI), 63-85; 6% of patients achieved a CR, and 69% achieved a PR. The median duration of response was 1.9 months (95% CI, 1.2-2.9), and 62% (95% CI, 46-74) of responding patients remained alive without new systemic therapy for at least 12 months from response. The common adverse reactions were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma-glutamyl transferase increased, lymphocytes decreased, and hypertension. Additional study is warranted to confirm safety with long-term use.
Przepiorka et al. (Tue,) conducted a cohort in chronic GvHD (n=65). Belumosudil was evaluated on overall response rate (ORR) through Cycle 7 Day 1 (95% CI 63-85). Belumosudil 200 mg daily achieved an overall response rate of 75% (95% CI, 63-85) through Cycle 7 Day 1 in patients with chronic GvHD after failure of at least two prior lines of systemic therapy.