Table 4. Efficacy parameters of the pivotal trials from the four approved drugs.
| Parameter | Pralatrexate (n = 109) | Romidepsin (n = 130) | Belinostat (n = 120) | Chidamide (n = 79) |
|---|---|---|---|---|
| PR, n (%) | 20 (18) | 14 (11) | 18 (15) | 11 (14) |
| CR + CRu, n (%) | 12 (11) | 19 (15) | 13 (11) | 11 (14) |
| ORR, n (%) | 32 (29) | 33 (25) | 31 (26) | 22 (28) |
| DOR > 3m, n (%) | 13 (12) | / | / | 19 (24) |
| PFS (month) | ||||
| Median | 3.5 | 4.0 | 1.6 | 2.1 |
| Range | 1 day–23.9 | / | / | 1 day–44.9 |
| OS (month) | ||||
| Median | 14.5 | 11.3 | 7.9 | 21.4 |
| Range | 1–24.1 | / | / | 0.3–50.1 |
| Response rates for individual subtypes, % | ||||
| PTCL NOS | 32 (19/59) | 29 (20/69) | 23 (18/77) | 22 (6/27) |
| ALCL | 35 (6/17) | 23 (5/22) | 13 (2/15) | 41 (7/17) |
| ALK negative | NA | 24 (5/21) | 15 (2/13) | 45 (5/11) |
| ALK positive/unknown | NA | 0 (0/1) | 0 (0/2) | 33 (2/6) |
| AITL | 8 (1/13) | 30 (8/27) | 45 (10/22) | 50 (5/10) |
| ENKL | 0 (0/2) | 0 (0/1) | 50 (1/2) | 19 (3/16) |
| Others | 33 (6/18) | 0 (0/11) | 0 (0/4) | 11 (1/9) |
PR, partial response; CR, complete response; CRu, complete response unconfirmed; DOR, duration of response; PFS, progression free survival; OS, overall survival; PTCL NOS, PTCL not otherwisespecified; ALCL, anaplastic large cell lymphoma; AITL, angioimmuoblastic T-cell lymphoma; ENKL, extranodal NK/T-cell lymphoma, nasal type.