Table 3.
ORR in the treatment population on day 28 per MN-CIBMTR response criteria
| Itacitinib, n (%) | Total, n (%) | |||||
|---|---|---|---|---|---|---|
| Response* | 200 mg | 300 mg | ||||
| First line (n = 6) | Steroid refractory (n = 8) | First line (n = 6) | Steroid refractory (n = 9) | First line (n = 12) | Steroid refractory (n = 17) | |
| All patients | ||||||
| CR | 5 (83.3) | 3 (37.5) | 4 (66.7) | 2 (22.2) | 9 (75.0) | 5 (29.4) |
| VGPR | 0 (0) | 0 (0) | 0 (0) | 1 (11.1) | 0 (0) | 1 (5.9) |
| PR | 0 (0) | 3 (37.5) | 0 (0) | 3 (33.3) | 0 (0) | 6 (35.3) |
| MR | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (8.3) | 0 (0) |
| PD | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| NR | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (8.3) | 0 (0) |
| Overall response† | 5 (83.3) | 6 (75.0) | 4 (66.7) | 6 (66.7) | 9 (75.0) | 12 (70.6) |
| 90% CI‡ | 41.8-99.1 | 40.0 -95.4 | 27.1-93.7 | 34.5-90.2 | 47.3-92.8 | 47.8-87.6 |
| Death or early withdrawal | 1 (16.7) | 2 (25.0) | 0 (0) | 3 (33.3) | 1 (8.3) | 5 (29.4) |
| Grade II aGVHD at baseline | (n = 3) | (n = 2) | (n = 4) | (n = 2) | (n = 7) | (n = 4) |
| CR | 3 (100) | 1 (50.0) | 3 (75.0) | 1 (50.0) | 6 (85.7) | 2 (50.0) |
| VGPR | 0 (0) | 0 (0) | 0 (0) | 1 (50.0) | 0 (0) | 1 (25.0) |
| PR | 0 (0) | 1 (50.0) | 0 (0) | 0 (0) | 0 (0) | 1 (25.0) |
| MR | 0 (0) | 0 (0) | 1 (25.0) | 0 (0) | 1 (16.7) | 0 (0) |
| PD | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| NA | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Overall response† | 3 (100) | 2 (100) | 3 (75.0) | 2 (100) | 6 (85.7) | 4 (100) |
| 90% CI‡ | 36.8-100 | 22.4-100 | 24.9-98.7 | 22.4-100 | 47.9-99.3 | 47.3-100 |
| Death or early withdrawal | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade III aGVHD at baseline | (n = 3) | (n = 5) | (n = 2) | (n = 6) | (n = 5) | (n = 11) |
| CR | 2 (66.7) | 2 (40.0) | 1 (50.0) | 0 (0) | 3 (60.0) | 2 (18.2) |
| VGPR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| PR | 0 (0) | 1 (20.0) | 0 (0) | 3 (50.0) | 0 (0) | 4 (36.4) |
| MR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| PD | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| NR | 0 (0) | 0 (0) | 1 (50.0) | 0 (0) | 1 (20.0) | 0 (0) |
| NA | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Overall response† | 2 (66.7) | 3 (60.0) | 1 (50.0) | 3 (50.0) | 3 (60.0) | 6 (54.6) |
| 90% CI‡ | 13.5-98.3 | 18.9-92.4 | 2.5-97.5 | 15.3-84.7 | 18.9-92.4 | 27.1-80.0 |
| Death or early withdrawal | 1 (33.3) | 2 (40.0) | 0 (0) | 3 (50.0) | 1 (20.0) | 5 (45.4) |
| Grade IV aGVHD at baseline | (n = 0) | (n = 1) | (n = 0) | (n = 1) | (n = 0) | (n = 2) |
| CR | NA | 0 (0) | NA | 1 (100) | NA | 1 (50.0) |
| VGPR | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
| PR | NA | 1 (100) | NA | 0 (0) | NA | 1 (50.0) |
| MR | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
| PD | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
| NR | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
| NA | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
| Overall response† | NA | 1 (100) | NA | 1 (100) | NA | 2 (100) |
| 90% CI‡ | NA | NA | NA | NA | NA | 22.4-100 |
| Death or early withdrawal | NA | 0 (0) | NA | 0 (0) | NA | 0 (0) |
MR, mixed response; NA, not applicable; NR, no response; PD, progressive disease.
*
Last response data available on or before day 28; data are not included for death or early withdrawal.
†
Patients with CR, VGPR, or PR.
‡
Calculated based on the exact method for binomial distributions.