Efficacy end points in both arms within mITT population
| Efficacy end point . | Belumosudil, 200 mg daily (n = 66) . | Belumosudil, 200 mg twice daily (n = 66) . | Total (N = 132) . |
|---|---|---|---|
| ORR | 49 (74) | 51 (77) | 100 (76) |
| 95% CI | 62-84 | 65-87 | 68-83 |
| ORR for responses occurring within 6 mo of treatment | 47 (71) | 48 (73) | 95 (72) |
| 95% CI | 59-82 | 60-83 | 64-80 |
| CR | 2 (3) | 1 (2) | 3 (2) |
| PR | 45 (68) | 47 (71) | 92 (70) |
| ORR for responses occurring within 12 mo of treatment | 49 (74) | 50 (76) | 99 (75) |
| 95% CI | 62-84 | 64-86 | 67-82 |
| CR | 4 (6) | 2 (3) | 6 (5) |
| PR | 45 (68) | 48 (73) | 93 (71) |
| Clinically significant improvement from baseline (LSS)* | |||
| Overall | 39 (59) | 41 (62) | 80 (61) |
| Responder, n/N (%) | 34/49 (69) | 36/51 (71) | 70/100 (70) |
| Nonresponder, n/N (%) | 5/17 (29) | 5/15 (33) | 10/32 (31) |
| FFS at 6 mo (95% CI), % | 73 (61-83) | 76 (63-84) | 75 (66-81) |
| FFS at 12 mo (95% CI), % | 57 (44-68) | 56 (43-67) | 56 (47-64) |
| Proportion with CS reduction | 42 (64) | 44 (67) | 86 (65) |
| Median CS reduction from baseline to greatest reduction, % | 38 | 50 | 50 |
| Mean change in CS dose from baseline, % | |||
| Overall | −43 | −48 | −45 |
| Responder | −49 | −58 | −54 |
| Nonresponder | −22 | −10 | −16 |
| CS discontinuation | 13 (20) | 15 (23) | 28 (21) |
| Efficacy end point . | Belumosudil, 200 mg daily (n = 66) . | Belumosudil, 200 mg twice daily (n = 66) . | Total (N = 132) . |
|---|---|---|---|
| ORR | 49 (74) | 51 (77) | 100 (76) |
| 95% CI | 62-84 | 65-87 | 68-83 |
| ORR for responses occurring within 6 mo of treatment | 47 (71) | 48 (73) | 95 (72) |
| 95% CI | 59-82 | 60-83 | 64-80 |
| CR | 2 (3) | 1 (2) | 3 (2) |
| PR | 45 (68) | 47 (71) | 92 (70) |
| ORR for responses occurring within 12 mo of treatment | 49 (74) | 50 (76) | 99 (75) |
| 95% CI | 62-84 | 64-86 | 67-82 |
| CR | 4 (6) | 2 (3) | 6 (5) |
| PR | 45 (68) | 48 (73) | 93 (71) |
| Clinically significant improvement from baseline (LSS)* | |||
| Overall | 39 (59) | 41 (62) | 80 (61) |
| Responder, n/N (%) | 34/49 (69) | 36/51 (71) | 70/100 (70) |
| Nonresponder, n/N (%) | 5/17 (29) | 5/15 (33) | 10/32 (31) |
| FFS at 6 mo (95% CI), % | 73 (61-83) | 76 (63-84) | 75 (66-81) |
| FFS at 12 mo (95% CI), % | 57 (44-68) | 56 (43-67) | 56 (47-64) |
| Proportion with CS reduction | 42 (64) | 44 (67) | 86 (65) |
| Median CS reduction from baseline to greatest reduction, % | 38 | 50 | 50 |
| Mean change in CS dose from baseline, % | |||
| Overall | −43 | −48 | −45 |
| Responder | −49 | −58 | −54 |
| Nonresponder | −22 | −10 | −16 |
| CS discontinuation | 13 (20) | 15 (23) | 28 (21) |
Unless otherwise noted, data are n (%).
Changes in cGVHD symptom burden were measured using LSS. Clinically meaningful improvement in symptom burden was defined as a decrease ≥ 7 points in LSS score.