Demographics and baseline disease characteristics
| . | Single-agent brentuximab vedotin . | Brentuximab vedotin + rituximab . | ||||
|---|---|---|---|---|---|---|
| DLBCL (n = 49) . | Other B-cell lymphoma (n = 19) . | DLBCL (n = 16) . | ||||
| No. . | % . | No. . | % . | No. . | % . | |
| Age, y | ||||||
| Median | 62 | 36 | 62 | |||
| Range | 17-85 | 16-68 | 22-78 | |||
| Male | 28 | 57 | 11 | 58 | 12 | 75 |
| Baseline ECOG performance status | ||||||
| 0 | 17 | 35 | 8 | 42 | 9 | 56 |
| 1 | 28 | 57 | 7 | 37 | 7 | 44 |
| 2 | 4 | 8 | 3 | 16 | 0 | |
| IPI score | ||||||
| 0 | 1 | 2 | 1 | 5 | 0 | |
| 1 | 9 | 18 | 1 | 5 | 4 | 25 |
| 2 | 11 | 22 | 6 | 32 | 6 | 38 |
| 3 | 14 | 29 | 4 | 21 | 3 | 19 |
| 4 | 8 | 16 | 0 | 0 | ||
| Unknown | 6 | 12 | 7 | 37 | 3 | 19 |
| DLBCL | ||||||
| DLBCL-NOS | 43 | 88 | 0 | 16 | 100 | |
| EBV-positive DLBCL of the elderly | 5 | 10 | 0 | 0 | ||
| T-cell-rich B-cell lymphoma | 1 | 2 | 0 | 0 | ||
| Other B-cell lymphomas | ||||||
| Gray zone lymphoma | 0 | 6 | 32 | 0 | ||
| PMBL | 0 | 6 | 32 | 0 | ||
| Follicular lymphoma | 0 | 3 | 16 | 0 | ||
| PTLD | 0 | 3 | 16 | 0 | ||
| Plasmablastic lymphoma | 0 | 1 | 5 | 0 | ||
| Transformed disease | 12 | 24 | 1 | 5 | 5 | 31 |
| Bulky disease, ≥5 cm on at least one baseline index lesion | 19 | 39 | 8 | 42 | 4 | 25 |
| Time from diagnosis to first dose, months | ||||||
| Median | 14.0 | 13.2 | 16.6 | |||
| Range | 0.8-124.4 | 1.7-191.2 | 0.9-347.3 | |||
| % CD30+ malignant cells* | ||||||
| Median | 25 | 47.5 | 50 | |||
| Range | 0-100 | 4-100 | 1-100 | |||
| sCD30, ng/mL† | ||||||
| Median | 206.1 | 385.1 | 389.7 | |||
| Range | 35.6-9428.6 | 33.2-21277.7 | 62.9-1070.2 | |||
| Stage at initial diagnosis‡ | ||||||
| I-II | 12 | 24 | 4 | 21 | 4 | 25 |
| III-IV | 35 | 71 | 13 | 68 | 12 | 75 |
| Refractory to most recent prior therapy | 40 | 82 | 14 | 74 | 9 | 56 |
| Refractory to first-line therapy | 37 | 76 | 17 | 89 | 10 | 63 |
| No. of prior cancer-related systemic therapies | ||||||
| Median | 3 | 3 | 3 | |||
| Range | 1-6 | 1-19 | 1-5 | |||
| Patients with prior: | ||||||
| Rituximab exposure | 47 | 96 | 18 | 95 | 15 | 94 |
| Anthracycline-containing regimen | 45 | 92 | 17 | 89 | 14 | 88 |
| Platinum-based systemic therapy | 34 | 65 | 12 | 63 | 10 | 63 |
| Cancer-related radiotherapy | 14 | 29 | 6 | 32 | 5 | 31 |
| Stem cell transplant | 10 | 20 | 3 | 16§ | 4 | 25 |
| Autologous | 10 | 20 | 2 | 11 | 4 | 25 |
| Allogeneic | 0 | 2 | 11 | 0 | ||
| . | Single-agent brentuximab vedotin . | Brentuximab vedotin + rituximab . | ||||
|---|---|---|---|---|---|---|
| DLBCL (n = 49) . | Other B-cell lymphoma (n = 19) . | DLBCL (n = 16) . | ||||
| No. . | % . | No. . | % . | No. . | % . | |
| Age, y | ||||||
| Median | 62 | 36 | 62 | |||
| Range | 17-85 | 16-68 | 22-78 | |||
| Male | 28 | 57 | 11 | 58 | 12 | 75 |
| Baseline ECOG performance status | ||||||
| 0 | 17 | 35 | 8 | 42 | 9 | 56 |
| 1 | 28 | 57 | 7 | 37 | 7 | 44 |
| 2 | 4 | 8 | 3 | 16 | 0 | |
| IPI score | ||||||
| 0 | 1 | 2 | 1 | 5 | 0 | |
| 1 | 9 | 18 | 1 | 5 | 4 | 25 |
| 2 | 11 | 22 | 6 | 32 | 6 | 38 |
| 3 | 14 | 29 | 4 | 21 | 3 | 19 |
| 4 | 8 | 16 | 0 | 0 | ||
| Unknown | 6 | 12 | 7 | 37 | 3 | 19 |
| DLBCL | ||||||
| DLBCL-NOS | 43 | 88 | 0 | 16 | 100 | |
| EBV-positive DLBCL of the elderly | 5 | 10 | 0 | 0 | ||
| T-cell-rich B-cell lymphoma | 1 | 2 | 0 | 0 | ||
| Other B-cell lymphomas | ||||||
| Gray zone lymphoma | 0 | 6 | 32 | 0 | ||
| PMBL | 0 | 6 | 32 | 0 | ||
| Follicular lymphoma | 0 | 3 | 16 | 0 | ||
| PTLD | 0 | 3 | 16 | 0 | ||
| Plasmablastic lymphoma | 0 | 1 | 5 | 0 | ||
| Transformed disease | 12 | 24 | 1 | 5 | 5 | 31 |
| Bulky disease, ≥5 cm on at least one baseline index lesion | 19 | 39 | 8 | 42 | 4 | 25 |
| Time from diagnosis to first dose, months | ||||||
| Median | 14.0 | 13.2 | 16.6 | |||
| Range | 0.8-124.4 | 1.7-191.2 | 0.9-347.3 | |||
| % CD30+ malignant cells* | ||||||
| Median | 25 | 47.5 | 50 | |||
| Range | 0-100 | 4-100 | 1-100 | |||
| sCD30, ng/mL† | ||||||
| Median | 206.1 | 385.1 | 389.7 | |||
| Range | 35.6-9428.6 | 33.2-21277.7 | 62.9-1070.2 | |||
| Stage at initial diagnosis‡ | ||||||
| I-II | 12 | 24 | 4 | 21 | 4 | 25 |
| III-IV | 35 | 71 | 13 | 68 | 12 | 75 |
| Refractory to most recent prior therapy | 40 | 82 | 14 | 74 | 9 | 56 |
| Refractory to first-line therapy | 37 | 76 | 17 | 89 | 10 | 63 |
| No. of prior cancer-related systemic therapies | ||||||
| Median | 3 | 3 | 3 | |||
| Range | 1-6 | 1-19 | 1-5 | |||
| Patients with prior: | ||||||
| Rituximab exposure | 47 | 96 | 18 | 95 | 15 | 94 |
| Anthracycline-containing regimen | 45 | 92 | 17 | 89 | 14 | 88 |
| Platinum-based systemic therapy | 34 | 65 | 12 | 63 | 10 | 63 |
| Cancer-related radiotherapy | 14 | 29 | 6 | 32 | 5 | 31 |
| Stem cell transplant | 10 | 20 | 3 | 16§ | 4 | 25 |
| Autologous | 10 | 20 | 2 | 11 | 4 | 25 |
| Allogeneic | 0 | 2 | 11 | 0 | ||
EBV, Epstein-Barr virus; ECOG, Eastern Cooperative Oncology Group; IPI, International Prognostic Index; NOS, not otherwise specified.
Per visual central review; includes 44 patients with DLBCL and 18 patients with other B-cell lymphomas who were treated with monotherapy, and 12 patients who were treated with combination therapy.
Includes 46 patients with DLBCL and 18 patients with other B-cell lymphomas who were treated with monotherapy, and 12 patients who were treated with combination therapy.
Four patients had unknown disease stage at study entry including 2 patients with DLBCL and 2 patients with other B-cell lymphomas who were treated with single-agent therapy.
One patient had both a prior autologous and a prior allogeneic SCT.