Baseline patient demographics and clinical characteristics in the safety evaluable set
| . | AITL (n = 38) . | PTCL-NOS∗ (n = 25) . | Total† (N = 65) . |
|---|---|---|---|
| Median age, y (min, max) | 66.27 (41.3, 87.4) | 66.88 (31.3, 87.7) | 66.34 (31.3, 87.7) |
| Sex, n (%) | |||
| Male | 22 (57.9) | 18 (72.0) | 41 (63.1) |
| Female | 16 (42.1) | 7 (28.0) | 24 (36.9) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 2 (5.3) | 2 (8.0) | 4 (6.2) |
| Not Hispanic or Latino | 36 (94.7) | 23 (92.0) | 61 (93.8) |
| Race, n (%) | |||
| White | 23 (60.5) | 22 (88.0) | 46 (70.8) |
| Black or African American | 1 (2.6) | 1 (4.0) | 3 (4.6) |
| Asian | 12 (31.6) | 0 | 12 (18.5) |
| Other | 2 (5.3) | 2 (8.0) | 4 (6.2) |
| ECOG performance status score, n (%) | |||
| 0 | 18 (47.4) | 8 (32.0) | 26 (40.0) |
| 1 | 13 (34.2) | 16 (64.0) | 31 (47.7) |
| 2 | 7 (18.4) | 1 (4.0) | 8 (12.3) |
| Stage at study entry, n (%) | |||
| I | 1 (1.5) | 0 | 1 (1.5) |
| II | 2 (3.1) | 2 (3.1) | 5 (7.7) |
| III | 11 (16.9) | 6 (9.2) | 17 (26.1) |
| IV | 24 (36.9) | 17 (26.2) | 42 (64.6) |
| Disease status at study entry, n (%)† | |||
| Relapse | 21 (55.3) | 13 (52.0) | 35 (53.8) |
| Refractory | 16 (42.1) | 12 (48.0) | 29 (44.6) |
| Unknown | 1 (2.6) | 0 | 1 (1.5) |
| No. of prior treatments, median (min, max) | 3.0 (1, 7) | 3.0 (1, 8) | 3.0 (1, 8) |
| Prior (any) cancer therapies, n‡ (%) | |||
| CHOP + CHOP-like | 22 (57.9) | 15 (60.0) | 37 (56.9) |
| CHOEP + CHOEP-like | 18 (47.4) | 8 (32.0) | 27 (41.5) |
| CHOP-R | 3 (7.9) | 2 (8.0) | 5 (7.7) |
| ICE + ICE-like | 11 (28.9) | 6 (24.0) | 17 (26.2) |
| Single agent‡ | 13 (34.2) | 13 (52.0) | 28 (43.1) |
| Belinostat | 1 (2.6) | 3 (12.0) | 4 (6.2) |
| Brentuximab vedotin | 5 (13.2) | 5 (20.0) | 11 (16.9) |
| Nivolumab | 4 (10.5) | 1 (4.0) | 5 (7.7) |
| Pralatrexate | 1 (2.6) | 4 (16.0) | 5 (7.7) |
| Romidepsin | 8 (21.1) | 7 (28.0) | 17 (26.2) |
| Immediate prior therapy to study drug, n‡ (%) | |||
| CHOP-R | 1 (2.6) | 0 (0.0) | 1 (1.5) |
| CHOP + CHOP-like | 7 (18.4) | 4 (16.0) | 11 (16.9) |
| CHOEP + CHOEP-like | 5 (13.2) | 2 (8.0) | 7 (10.8) |
| ICE + ICE-like | 3 (7.9) | 2 (8.0) | 5 (7.7) |
| Single agent | 13 (34.2) | 11 (44.0) | 26 (40.0) |
| Brentuximab vedotin | 4 (10.5) | 4 (16.0) | 8 (12.3) |
| Romidepsin | 5 (13.2) | 1 (4.0) | 8 (12.3) |
| Other | 9 (23.7) | 6 (24.0) | 15 (23.1) |
| Prior stem cell transplant (autologous), n (%) | 17 (44.7) | 8 (32.0) | 25 (38.5) |
| . | AITL (n = 38) . | PTCL-NOS∗ (n = 25) . | Total† (N = 65) . |
|---|---|---|---|
| Median age, y (min, max) | 66.27 (41.3, 87.4) | 66.88 (31.3, 87.7) | 66.34 (31.3, 87.7) |
| Sex, n (%) | |||
| Male | 22 (57.9) | 18 (72.0) | 41 (63.1) |
| Female | 16 (42.1) | 7 (28.0) | 24 (36.9) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 2 (5.3) | 2 (8.0) | 4 (6.2) |
| Not Hispanic or Latino | 36 (94.7) | 23 (92.0) | 61 (93.8) |
| Race, n (%) | |||
| White | 23 (60.5) | 22 (88.0) | 46 (70.8) |
| Black or African American | 1 (2.6) | 1 (4.0) | 3 (4.6) |
| Asian | 12 (31.6) | 0 | 12 (18.5) |
| Other | 2 (5.3) | 2 (8.0) | 4 (6.2) |
| ECOG performance status score, n (%) | |||
| 0 | 18 (47.4) | 8 (32.0) | 26 (40.0) |
| 1 | 13 (34.2) | 16 (64.0) | 31 (47.7) |
| 2 | 7 (18.4) | 1 (4.0) | 8 (12.3) |
| Stage at study entry, n (%) | |||
| I | 1 (1.5) | 0 | 1 (1.5) |
| II | 2 (3.1) | 2 (3.1) | 5 (7.7) |
| III | 11 (16.9) | 6 (9.2) | 17 (26.1) |
| IV | 24 (36.9) | 17 (26.2) | 42 (64.6) |
| Disease status at study entry, n (%)† | |||
| Relapse | 21 (55.3) | 13 (52.0) | 35 (53.8) |
| Refractory | 16 (42.1) | 12 (48.0) | 29 (44.6) |
| Unknown | 1 (2.6) | 0 | 1 (1.5) |
| No. of prior treatments, median (min, max) | 3.0 (1, 7) | 3.0 (1, 8) | 3.0 (1, 8) |
| Prior (any) cancer therapies, n‡ (%) | |||
| CHOP + CHOP-like | 22 (57.9) | 15 (60.0) | 37 (56.9) |
| CHOEP + CHOEP-like | 18 (47.4) | 8 (32.0) | 27 (41.5) |
| CHOP-R | 3 (7.9) | 2 (8.0) | 5 (7.7) |
| ICE + ICE-like | 11 (28.9) | 6 (24.0) | 17 (26.2) |
| Single agent‡ | 13 (34.2) | 13 (52.0) | 28 (43.1) |
| Belinostat | 1 (2.6) | 3 (12.0) | 4 (6.2) |
| Brentuximab vedotin | 5 (13.2) | 5 (20.0) | 11 (16.9) |
| Nivolumab | 4 (10.5) | 1 (4.0) | 5 (7.7) |
| Pralatrexate | 1 (2.6) | 4 (16.0) | 5 (7.7) |
| Romidepsin | 8 (21.1) | 7 (28.0) | 17 (26.2) |
| Immediate prior therapy to study drug, n‡ (%) | |||
| CHOP-R | 1 (2.6) | 0 (0.0) | 1 (1.5) |
| CHOP + CHOP-like | 7 (18.4) | 4 (16.0) | 11 (16.9) |
| CHOEP + CHOEP-like | 5 (13.2) | 2 (8.0) | 7 (10.8) |
| ICE + ICE-like | 3 (7.9) | 2 (8.0) | 5 (7.7) |
| Single agent | 13 (34.2) | 11 (44.0) | 26 (40.0) |
| Brentuximab vedotin | 4 (10.5) | 4 (16.0) | 8 (12.3) |
| Romidepsin | 5 (13.2) | 1 (4.0) | 8 (12.3) |
| Other | 9 (23.7) | 6 (24.0) | 15 (23.1) |
| Prior stem cell transplant (autologous), n (%) | 17 (44.7) | 8 (32.0) | 25 (38.5) |
ALK, anaplastic lymphoma kinase; CHOEP, cyclophosphamide, doxorubicin, doxorubicin hydrochloride, etoposide, prednisolone, prednisone, vincristine, and vincristine sulfate; CHOEP-like, carmustine, cyclophosphamide, cytarabine, doxorubicin, etoposide, melphalan, methotrexate, prednisone, and vincristine; CHOP, cyclophosphamide, doxorubicin, doxorubicin hydrochloride, prednisolone, prednisone, vincristine, and vincristine sulfate; CHOP-like, cyclophosphamide, calcium folinate, epirubicin, etoposide, dexamethasone, eexrazoxane, doxorubicin, prednisolone, prednisone, pralatrexate, vincristine, vincristine sulfate, and procarbazine; CHOP-R, cyclophosphamide, doxorubicin, etoposide, prednisolone, prednisone, methotrexate, rituximab, vincristine, and vincristine sulfate; ECOG, Eastern Cooperative Oncology Group; ICE, ifosfamide, carboplatin, and etoposide; ICE-like, carboplatin, etoposide, and ifosfamide; ICE-like, carboplatin, cisplatin, dexamethasone, etoposide, ifosfamide, mesna; single agent, alisertib, belinostat, brentuximab vedotin, calcium folinate, chidamide, lambrolizumab, lenalidomide, lirilumab, nivolumab, pralatrexate, rituximab, romidepsin, and ruxolitinib; max, maximum; min, minimum.
PTCL-NOS = includes all patients regardless of CXCL12 status.
Total = 38 AITL + 25 PTCL-NOS + 2 “other” (ALCL ALK-negative and PTCL-subtype not specified per protocol).
Prior therapies (>5% of patients); patients may have received >1 therapy: CHOEP, CHOEP-like, CHOP, CHOP-like, CHOP-R, ICE, and ICE-like.