Table 1.
Patient Baseline Demographics, Clinical Characteristics, and Clinical Response
| Characteristics | All Patients, N = 32, n (%) | Evaluable for Response, n = 30 |
ORR,* n (%) | ||||
|---|---|---|---|---|---|---|---|
| CR | PR | SD | PD | NE | |||
| Sex | |||||||
| Male | 19 (59) | 0 | 13 | 1 | 4 | 1 | 13 of 18 (72) |
| Female | 13 (41) | 1 | 7 | 3 | 1 | 1 | 8 of 12 (67) |
| Age, years, median (range) | 62 (20-87) | 78 | 60 (38-87) | 60 (20-82) | 64 (57-77) | 60 (50-70) | |
| Clinical stage | |||||||
| All | 32 (100) | 1 | 20 | 4 | 5 | 2 | 21 of 30 (70) |
| IB | 4 (13) | 0 | 3 | 1 | 0 | 0 | 3 of 4 (75) |
| IIB | 18 (56) | 0 | 14 | 2 | 2 | 0 | 14 of 18 (78) |
| IV/SS† | 10 (31) | 1 | 3 | 1 | 3 | 2 | 4 of 8 (50) |
| Adverse prognostic factors | |||||||
| LCT or FMF | 29 (90) | 1 | 19 | 3 | 5 | 1 | 20 of 28 (71) |
| LCT | 16 (50) | 1 | 9 | 2 | 3 | 1 | 10 of 15 (67) |
| FMF | 8 (25) | 0 | 7 | 1 | 0 | 0 | 7 of 8 (88) |
| LCT + FMF | 5 (16) | 0 | 3 | 0 | 2 | 0 | 3 of 5 (60) |
| No. of prior systemic therapies | |||||||
| < 3 | 15 (47) | 0 | 8 | 2 | 4 | 1 | 8 of 14 (57) |
| ≥ 3 | 17 (53) | 1 | 12 | 2 | 1 | 1 | 13 of 16 (81) |
| CD30 grouping at screening | |||||||
| A (< 10%) | 14 (44) | 0 | 7 | 4 | 2 | 1 | 7 of 13 (54) |
| B (10% to 50%) | 14 (44) | 0 | 11 | 0 | 3 | 0 | 11 of 14 (79) |
| C (> 50%) | 4 (13) | 1 | 2 | 0 | 0 | 1 | 3 of 3 (100) |
Abbreviations: CR, complete response; FMF, folliculotropic mycosis fungoides; LCT, large-cell transformation; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease; SS, Sézary syndrome.
*
Objective clinical response was observed in 21 (70%) of the 30 efficacy-evaluable patients
†
Of 10 stage IV patients, three patients had SS with one CR, one PR, and one PD; one patient was stage IVB who had PR.