Summary of tumor response in the efficacy analysis set (n = 57)
| . | N . | Overall response rate . | Disease control rate (≥SD) . | ||
|---|---|---|---|---|---|
| Central assessment . | Local assessment . | Central assessment . | Local assessment . | ||
| Response, n (%) | 57 | 11 (19.3)∗ | 15 (26.3)† | 26 (45.6) | 31 (54.4) |
| 90% CI | 11.2-29.9 | 17.0-37.6 | 34.3-57.3 | 42.7-65.7 | |
| CR: 5 (8.8), PR: 6 (10.5) | CR: 4 (7.0), PR: 11 (19.3) | ||||
| Subgroup analysis, n (%) | |||||
| PTCL subtype by central review | |||||
| PTCL-NOS | 37 | 6 (16.2) | 11 (29.7) | 18 (48.6) | 20 (54.1) |
| AITL | 17 | 5 (29.4) | 4 (23.5) | 8 (47.1) | 11 (64.7) |
| ALCL, ALK negative | 3 | 0 | 0 | 0 | 0 |
| Clinical stage | |||||
| Stage I | 1 | 0 | 0 | 0 | 0 |
| Stage II | 5 | 2 (40.0) | 3 (60.0) | 4 (80.0) | 5 (100.0) |
| Stage III | 28 | 5 (17.9) | 8 (28.6) | 14 (50.0) | 17 (60.7) |
| Stage IV | 23 | 4 (17.4) | 4 (17.4) | 8 (34.8) | 9 (39.1) |
| Relapsed/refractory status | |||||
| Relapsed | 37 | 7 (18.9) | 11 (29.7) | 18 (48.6) | 20 (54.1) |
| Refractory | 16 | 4 (25.0) | 4 (25.0) | 7 (43.8) | 10 (62.5) |
| Sex | |||||
| Male | 39 | 7 (17.9) | 9 (23.1) | 16 (41.0) | 21 (53.8) |
| Female | 18 | 4 (22.2) | 6 (33.3) | 10 (55.6) | 10 (55.6) |
| Age, y | |||||
| <65 | 18 | 3 (16.7) | 4 (22.2) | 9 (50.0) | 11 (61.1) |
| ≥65 | 39 | 8 (20.5) | 11 (28.2) | 17 (43.6) | 20 (51.3) |
| . | N . | Overall response rate . | Disease control rate (≥SD) . | ||
|---|---|---|---|---|---|
| Central assessment . | Local assessment . | Central assessment . | Local assessment . | ||
| Response, n (%) | 57 | 11 (19.3)∗ | 15 (26.3)† | 26 (45.6) | 31 (54.4) |
| 90% CI | 11.2-29.9 | 17.0-37.6 | 34.3-57.3 | 42.7-65.7 | |
| CR: 5 (8.8), PR: 6 (10.5) | CR: 4 (7.0), PR: 11 (19.3) | ||||
| Subgroup analysis, n (%) | |||||
| PTCL subtype by central review | |||||
| PTCL-NOS | 37 | 6 (16.2) | 11 (29.7) | 18 (48.6) | 20 (54.1) |
| AITL | 17 | 5 (29.4) | 4 (23.5) | 8 (47.1) | 11 (64.7) |
| ALCL, ALK negative | 3 | 0 | 0 | 0 | 0 |
| Clinical stage | |||||
| Stage I | 1 | 0 | 0 | 0 | 0 |
| Stage II | 5 | 2 (40.0) | 3 (60.0) | 4 (80.0) | 5 (100.0) |
| Stage III | 28 | 5 (17.9) | 8 (28.6) | 14 (50.0) | 17 (60.7) |
| Stage IV | 23 | 4 (17.4) | 4 (17.4) | 8 (34.8) | 9 (39.1) |
| Relapsed/refractory status | |||||
| Relapsed | 37 | 7 (18.9) | 11 (29.7) | 18 (48.6) | 20 (54.1) |
| Refractory | 16 | 4 (25.0) | 4 (25.0) | 7 (43.8) | 10 (62.5) |
| Sex | |||||
| Male | 39 | 7 (17.9) | 9 (23.1) | 16 (41.0) | 21 (53.8) |
| Female | 18 | 4 (22.2) | 6 (33.3) | 10 (55.6) | 10 (55.6) |
| Age, y | |||||
| <65 | 18 | 3 (16.7) | 4 (22.2) | 9 (50.0) | 11 (61.1) |
| ≥65 | 39 | 8 (20.5) | 11 (28.2) | 17 (43.6) | 20 (51.3) |