Table 3.
Efficacy assessment of the phase 2 study
| Characteristics | ORR (%) | CR (%) | SD (%) | PD (%) | Not evaluable (%)* |
|---|---|---|---|---|---|
| Phase 2 (n = 113) | 68 (60.2) | 46 (40.7) | 11 (9.7) | 30 (26.5) | 4 (3.5) |
| IPI | |||||
| 0–1 (n = 34) | 23 (67.6) | 18 (52.9) | 3 (8.8) | 7 (20.6) | 1 (2.9) |
| 2 (n = 33) | 20 (60.6) | 13 (39.4) | 6 (18.2) | 7 (21.2) | 0 (0) |
| 3 (n = 24) | 14 (58.3) | 7 (29.2) | 1 (4.2) | 8 (33.3) | 1 (4.2) |
| 4–5 (n = 22) | 11 (50.0) | 8 (36.4) | 1 (4.5) | 9 (40.9) | 2 (9.1) |
| Pathology subtypes | |||||
| AITL (n = 41) | 27 (65.9) | 17 (41.5) | 4 (9.8) | 8 (19.5) | 2 (4.9) |
| PTCL-NOS (n = 48) | 26 (54.2) | 20 (41.7) | 5 (10.4) | 16 (33.3) | 1 (2.1) |
| ALCL (ALK-) (n = 17) | 13 (76.5) | 8 (47.1) | 2 (2.8) | 2 (2.8) | 0 (0) |
| EATL (n = 7) | 2 (28.6) | 1 (14.3) | 0 (0) | 4 (57.1) | 1 (14.3) |
*Patients without efficacy assessments due to premature discontinuation by AEs.
ORR, overall response rate; CR, complete response; SD, stable disease; PD, progressive disease; IPI, international prognostic index; AITL, angioimmunoblastic T cell lymphoma; PTCL-NOS, peripheral T cell lymphoma-not otherwise specified; ALCL, anaplastic large cell lymphoma; EATL, enteropathy-associated T-cell lymphoma; AE, adverse event.