Table 4.
Efficacy by subgroup
| Subgroup | ORR (CR + CRu + PR), % (95% CI) | PFS, median (95% CI), mo | OS, median (95% CI), mo |
|---|---|---|---|
| Overall (N = 221) | 40.7 (34.2-47.5) | 4.6 (3.2-5.6) | 16.3 (13.1-22.6) |
| R/R status at most recent treatment | |||
| Relapse (n = 54) | 48.1 (34.3-62.2) | 8.0 (4.6-11.1) | 22.9 (14.6 to NE) |
| Refractory (n = 119) | 37.8 (29.1-47.2) | 3.2 (2.5-4.6) | 14.6 (10.3-23.6) |
| Number of prior chemotherapy lines | |||
| 1 (n = 76) | 55.3 (43.4-66.7) | 6.7 (4.4-10.7) | 24.2 (17.0 to NE) |
| 2 (n = 60) | 31.7 (20.3-45.0) | 3.1 (1.7-7.7) | 12.0 (9.0-22.9) |
| 3 (n = 38) | 50.0 (33.4-66.6) | 4.6 (1.6-8.5) | 22.5 (9.6-28.2) |
| ≥4 (n = 47) | 21.3 (10.7-35.7) | 3.0 (1.4-4.9) | 10.0 (6.1-15.2) |
| Type of prior chemotherapy | |||
| Anthracycline-based only (n = 102) | 50.0 (39.9-60.1) | 4.8 (3.2-7.8) | 20.5 (14.4-26.7) |
| Anthracycline, platinum, gemcitabine-based (n = 53) | 32.1 (19.9-46.3) | 4.2 (1.6-7.7) | 11.2 (6.8-23.4) |
| Anthracycline, platinum-based (n = 33) | 27.3 (13.3-45.5) | 3.0 (1.4-10.6) | 10.4 (3.8-23.6) |
| Not anthracycline or platinum or gemcitabine-based (n = 18) | 50.0 (26.0-74.0) | 7.8 (3.9-14.1) | 17.0 (10.6 to NE) |
| PTCL histological subtype by central review | |||
| PTCL-NOS (n = 108) | 40.7 (31.4-50.6) | 4.8 (3.3-6.7) | 15.4 (10.5-24.2) |
| AITL (n = 47) | 42.6 (28.3-57.8) | 1.9 (1.5-6.0) | 18 (11.9-28.2) |
| ALCL, ALK negative (n = 26) | 46.2 (26.6-66.6) | 4.8 (1.4 to NE) | 19.3 (4.2 to NE) |
| tMF (n = 12) | 25.0 (5.5-57.2) | 1.7 (1.4-8.1) | 13.6 (1.7-NE) |
| Type of prior systemic therapy | |||
| Chemotherapy only (n = 162) | 42.6 (34.9-50.6) | 4.7 (3.3-6.6) | 18.3 (14.4-24.2) |
| Chemotherapy and transplant (n = 26) | 50.0 (29.9-70.1) | 10.6 (1.4 to NE) | 23.6 (8.2 to NE) |
| Chemotherapy and other (n = 16) | 31.3 (11.0-58.7) | 1.6 (0.6-3.5) | 10.0 (3.2-13.1) |
ALK, anaplastic lymphoma kinase; NE, not estimable; tMF, transformed mycosis fungoides; u, unconfirmed.