Characterization of patients who remain in remission per the investigator following treatment with brentuximab vedotin
| . | In remission* (n = 18) . | All other responders† (n = 55) . | Nonresponders (n = 29) . |
|---|---|---|---|
| Demographics and baseline disease characteristics | |||
| Median age in years (range) | 26.5 (15-63) | 32.0 (18-69) | 35.0 (18-77) |
| Female, n (%) | 12 (67) | 31 (56) | 11 (38) |
| ECOG performance status, n (%) | |||
| Grade 0 | 10 (56) | 22 (40) | 10 (34) |
| Grade 1 | 8 (44) | 33 (60) | 19 (66) |
| Relapsed relative to most recent therapy,‡ n (%) | 14 (78) | 29 (53) | 16 (55) |
| Primary refractory disease,§ n (%) | 13 (72) | 36 (65) | 23 (79) |
| Stage, n (%) | |||
| Stage I/II | 14 (78) | 27 (49) | 10 (34) |
| Stage III | 3 (17) | 14 (25) | 10 (34) |
| Stage IV | 1 (6) | 11 (20) | 8 (28) |
| Median time in months from initial diagnosis to first dose (range) | 36.5 (12-99) | 46.1 (14-219) | 38.1 (12-114) |
| Median time in months from last auto-SCT to relapse prior to b-v (range) | 7.8 (1-63) | 6.4 (1-131) | 6.5 (0-53) |
| Median SPD (cm2) per investigator (range) | 16.1 (2-55) | 24.5 (2-276) | 29.1 (3-157) |
| Exposure | |||
| Median duration of treatment in weeks (range) | 43.6 (13-56) | 30.1 (9-54) | 20.9 (3-52) |
| Median number of cycles (range) | 13.5 (4-16) | 10 (3-16) | 7 (1-16) |
| Median % relative dose intensity (range) | 94.5 (73-103) | 96.0 (69-107) | 98.7 (79-102) |
| Adverse events, n (%) | |||
| Serious adverse event | 3 (17) | 11 (20) | 11 (38) |
| Adverse event discontinuation | 5 (28) | 9 (16) | 6 (21) |
| ≥Grade 3 adverse event | 11 (61) | 28 (51) | 17 (59) |
| Peripheral neuropathy (standardized MedDRA query) | 13 (72) | 28 (51) | 15 (52) |
| . | In remission* (n = 18) . | All other responders† (n = 55) . | Nonresponders (n = 29) . |
|---|---|---|---|
| Demographics and baseline disease characteristics | |||
| Median age in years (range) | 26.5 (15-63) | 32.0 (18-69) | 35.0 (18-77) |
| Female, n (%) | 12 (67) | 31 (56) | 11 (38) |
| ECOG performance status, n (%) | |||
| Grade 0 | 10 (56) | 22 (40) | 10 (34) |
| Grade 1 | 8 (44) | 33 (60) | 19 (66) |
| Relapsed relative to most recent therapy,‡ n (%) | 14 (78) | 29 (53) | 16 (55) |
| Primary refractory disease,§ n (%) | 13 (72) | 36 (65) | 23 (79) |
| Stage, n (%) | |||
| Stage I/II | 14 (78) | 27 (49) | 10 (34) |
| Stage III | 3 (17) | 14 (25) | 10 (34) |
| Stage IV | 1 (6) | 11 (20) | 8 (28) |
| Median time in months from initial diagnosis to first dose (range) | 36.5 (12-99) | 46.1 (14-219) | 38.1 (12-114) |
| Median time in months from last auto-SCT to relapse prior to b-v (range) | 7.8 (1-63) | 6.4 (1-131) | 6.5 (0-53) |
| Median SPD (cm2) per investigator (range) | 16.1 (2-55) | 24.5 (2-276) | 29.1 (3-157) |
| Exposure | |||
| Median duration of treatment in weeks (range) | 43.6 (13-56) | 30.1 (9-54) | 20.9 (3-52) |
| Median number of cycles (range) | 13.5 (4-16) | 10 (3-16) | 7 (1-16) |
| Median % relative dose intensity (range) | 94.5 (73-103) | 96.0 (69-107) | 98.7 (79-102) |
| Adverse events, n (%) | |||
| Serious adverse event | 3 (17) | 11 (20) | 11 (38) |
| Adverse event discontinuation | 5 (28) | 9 (16) | 6 (21) |
| ≥Grade 3 adverse event | 11 (61) | 28 (51) | 17 (59) |
| Peripheral neuropathy (standardized MedDRA query) | 13 (72) | 28 (51) | 15 (52) |
b-v, brentuximab vedotin.
Patients with a best response of CR (n = 16) or PR (n = 2) on treatment who are still on study and in remission without the start of new anticancer therapy, other than allogeneic stem cell transplant. The 2 patients with a PR to brentuximab vedotin achieved CR subsequent to transplant.
Patients with a best response of CR or PR on treatment who experienced progressive disease, initiated new therapy, or discontinued from the study for reasons including death, lost to follow-up, withdrawal of consent, and investigator decision.
Best response of CR or PR to most recent prior therapy.
No CR or relapse within 3 months of front-line therapy.