Table 2.
Response rates in the mITT population
| Response Data are n (%) unless stated otherwise |
Belumosudil 200 mg once daily (N = 30) |
|---|---|
| ORR | 22 (73.3%) |
| 95% CI | 54.1–87.7% |
| PR | 22 (73.3%) |
| ORR for responses occurring within 6 months of treatment | 20 (66.7%) |
| 95% CI | 47.2–82.7% |
| PR | 20 (66.7%) |
| Median DOR, weeks (95% CI) | NR (20.3–NR) |
| Median TTR, weeks (range) | 4.3 (3.9–48.1) |
| Improvement from baseline based on LSSa | |
| Overall | 15 (50.0%) |
| Responder, n/N (%) | 12/22 (54.5%) |
| Non-responder, n/N (%) | 3/8 (37.5%) |
| Median duration of improvement, weeks (range) | 16 (4–69) |
| ≥ 16 weeks | 9 (30.0%) |
| ≥ 24 weeks | 5 (16.7%) |
| ≥ 32 weeks | 5 (16.7%) |
| Improvement from baseline based on LSS on two consecutive visitsa | |
| Overall | 10 (33.3%) |
| Responder, n/N (%) | 9/22 (40.9%) |
| Non-responder, n/N (%) | 1/8 (12.5%) |
| FFS, % (95% CI) | |
| Median, months | NR (7.8–NR) |
| 6 months | 73 (54–86%) |
| 12 months | 56 (37–72%) |
| TTNT, % (95% CI) | |
| Median, months | NR (8.9–NR) |
| 6 months | 77 (57–88%) |
| 12 months | 63 (43–77%) |
| OS, % (95% CI) | |
| Median, months | NR (NR–NR) |
| 6 months | 97 (79–100%) |
| 12 months | 87 (68–95%) |
CI confidence interval, DOR duration of response, FFS failure-free-survival, LSS Lee symptom scale, NR not reached, ORR overall response rate, OS overall survival, PR partial response, TTNT time-to-next-treatment, TTR time-to-response
aClinically meaningful improvement in cGVHD symptom burden defined as a decrease ≥ 7 points in LSS score from baseline