Analysis of disease response per investigator assessment
| . | Cohort 1 (ENKTL) (N = 22) . | Cohort 2a PTCL-NOS (n = 21) . | Cohort 2b AITL (n = 11) . | Cohort 2c ALCL (n = 12) . | Cohort 2 Total (N = 44) . | Cohort 3 (MF and SS) (N = 11) . |
|---|---|---|---|---|---|---|
| BOR, n (%) | ||||||
| CR | 4 (18.2) | 3 (14.3) | 1 (9.1) | 0 (0.0) | 4 (9.1) | 1 (9.1) |
| PR | 3 (13.6) | 2 (9.5) | 1 (9.1) | 2 (16.7) | 5 (11.4) | 4 (36.4) |
| Stable disease | 1 (4.5) | 3 (14.3) | 3 (27.3) | 0 (0.0) | 6 (13.6) | 3 (27.3) |
| Indeterminate response | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 1 (2.3) | 0 (0.0) |
| Progressive disease | 11 (50.0) | 11 (52.4) | 4 (36.4) | 6 (50.0) | 21 (47.7) | 1 (9.1) |
| Discontinued prior to first assessment | 3 (13.6) | 2 (9.5) | 2 (18.2) | 3 (25.0) | 7 (15.9) | 2 (18.2) |
| ORR,∗ n (%) | 7 (31.8) | 5 (23.8) | 2 (18.2) | 2 (16.7) | 9 (20.5) | 5 (45.5) |
| 95% CI† | (13.9-54.9) | (8.2-47.2) | (2.3-51.8) | (2.1-48.4) | (9.8-35.3) | (16.7-76.6) |
| TTR, mo‡ | ||||||
| n | 7 | 5 | 2 | 2 | 9 | 5 |
| Median | 5.8 | 4.6 | 2.5 | 2.7 | 2.9 | 6.8 |
| Min, max | 2.1, 13.9 | 2.8, 5.5 | 2.1, 2.9 | 2.7, 2.7 | 2.1, 5.5 | 2.6, 11.1 |
| Time to CR, mo | ||||||
| n | 4 | 3 | 1 | 0 | 4 | 1 |
| Median | 8.6 | 4.6 | 2.1 | NA | 3.7 | 14.3 |
| Min, max | 2.1, 13.9 | 2.8, 5.5 | 2.1, 2.1 | NA | 2.1, 5.5 | 14.3, 14.3 |
| . | Cohort 1 (ENKTL) (N = 22) . | Cohort 2a PTCL-NOS (n = 21) . | Cohort 2b AITL (n = 11) . | Cohort 2c ALCL (n = 12) . | Cohort 2 Total (N = 44) . | Cohort 3 (MF and SS) (N = 11) . |
|---|---|---|---|---|---|---|
| BOR, n (%) | ||||||
| CR | 4 (18.2) | 3 (14.3) | 1 (9.1) | 0 (0.0) | 4 (9.1) | 1 (9.1) |
| PR | 3 (13.6) | 2 (9.5) | 1 (9.1) | 2 (16.7) | 5 (11.4) | 4 (36.4) |
| Stable disease | 1 (4.5) | 3 (14.3) | 3 (27.3) | 0 (0.0) | 6 (13.6) | 3 (27.3) |
| Indeterminate response | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 1 (2.3) | 0 (0.0) |
| Progressive disease | 11 (50.0) | 11 (52.4) | 4 (36.4) | 6 (50.0) | 21 (47.7) | 1 (9.1) |
| Discontinued prior to first assessment | 3 (13.6) | 2 (9.5) | 2 (18.2) | 3 (25.0) | 7 (15.9) | 2 (18.2) |
| ORR,∗ n (%) | 7 (31.8) | 5 (23.8) | 2 (18.2) | 2 (16.7) | 9 (20.5) | 5 (45.5) |
| 95% CI† | (13.9-54.9) | (8.2-47.2) | (2.3-51.8) | (2.1-48.4) | (9.8-35.3) | (16.7-76.6) |
| TTR, mo‡ | ||||||
| n | 7 | 5 | 2 | 2 | 9 | 5 |
| Median | 5.8 | 4.6 | 2.5 | 2.7 | 2.9 | 6.8 |
| Min, max | 2.1, 13.9 | 2.8, 5.5 | 2.1, 2.9 | 2.7, 2.7 | 2.1, 5.5 | 2.6, 11.1 |
| Time to CR, mo | ||||||
| n | 4 | 3 | 1 | 0 | 4 | 1 |
| Median | 8.6 | 4.6 | 2.1 | NA | 3.7 | 14.3 |
| Min, max | 2.1, 13.9 | 2.8, 5.5 | 2.1, 2.1 | NA | 2.1, 5.5 | 14.3, 14.3 |