Characterization of patients with a best response of CR (N = 34) following treatment with single-agent brentuximab vedotin
| . | CR no PD no EOS and no New treatment (N = 9) . | CR with PD or death due to disease (N = 14) . | All other CR (N = 11) . |
|---|---|---|---|
| Age in years | |||
| Median | 27.0 | 41.0 | 28.0 |
| Range | 15, 63 | 21, 51 | 20, 54 |
| 95% CI for median | 20.6, 45.0 | 32.4, 44.2 | 23.8, 37.5 |
| Sex | |||
| Male, n (%) | 5 (56) | 4 (29) | 2 (18) |
| 95% CI for male percentage | 21.2, 86.3 | 8.4, 58.1 | 2.3, 51.8 |
| Female, n (%) | 4 (44) | 10 (71) | 9 (82) |
| 95% CI for male percentage | 13.7, 78.8 | 41.9, 91.6 | 48.2, 97.7 |
| ECOG performance status | |||
| Grade 0, n (%) | 5 (56) | 8 (57) | 5 (45) |
| 95% CI for ECOG 0 percentage | 21.2, 86.3 | 28.9, 82.3 | 16.7, 76.6 |
| Grade 1, n (%) | 4 (44) | 6 (43) | 6 (55) |
| 95% CI for ECOG 1 percentage | 13.7, 78.8 | 17.7, 71.1 | 23.4, 83.3 |
| Disease status relative to most recent prior therapy* | |||
| Relapse, n (%) | 6 (67) | 8 (57) | 9 (82) |
| 95% CI for relapse percentage | 29.9, 92.5 | 28.9, 82.3 | 48.2, 97.7 |
| Refractory, n (%) | 3 (33) | 6 (43) | 2 (18) |
| 95% CI for refractory percentage | 7.5, 70.1 | 17.7, 71.1 | 2.3, 51.8 |
| Primary refractory disease, n (%)† | 6 (67) | 9 (64) | 9 (82) |
| 95% CI for percentage | 54.1, 100.0 | 66.4, 100.0 | 66.4, 100.0 |
| Stage | |||
| Stage I/II, n (%) | 7 (78) | 9 (64) | 8 (73) |
| 95% for I/II percentage | 40.0, 97.2 | 35.1, 87.2 | 39.0, 94.0 |
| Stage III | 1 (11) | 2 (14) | 2 (18) |
| 95% CI for III percentage | 0.3, 48.2 | 1.8, 42.8 | 2.3, 51.8 |
| Stage IV | 1 (11) | 2 (14) | 1 (9) |
| 95% CI for IV percentage | 0.3, 48.2 | 1.8, 42.8 | 0.2, 41.3 |
| Median time in months from initial diagnosis to first dose (range) | −37.5 (-98.7, −16.4) | −45.8 (-184.7, −14.4) | −29.7 (-134.6, −21.0) |
| 95% CI | −67.9, −27.3 | −90.5, −35.3 | −66.7, −21.3 |
| Median time in months from most recent relapse to first dose (range)‡ | −1.3 (-5.6, −1.1) | −3.0 (-4.0, −0.9) | −2.3 (-8.5, −0.7) |
| 95% CI | −4.9, −0.3 | −3.7, −1.7 | −6.2, −1.4 |
| Median SPD (cm2) per investigator (range) | 11.3 (2.0, 55.2) | 18.4 (2.5, 59.0) | 16.7 (4.0, 116.1) |
| 95% CI | 4.4, 41.2 | 13.3, 33.8 | 4.5, 46.3 |
| Extranodal status, n (%)§ | |||
| No | 4 (44) | 9 (64) | 5 (45) |
| 95% for No percentage | 13.7, 78.8 | 35.1, 87.2 | 16.7, 76.6 |
| Yes | 5 (56) | 5 (36) | 6 (55) |
| 95% for Yes percentage | 21.2, 86.3 | 12.8, 64.9 | 23.4, 83.3 |
| Number of prior cancer-related systemic therapy regimens¶ | |||
| Median | 4.0 | 3.5 | 2.0 |
| Range | 2, 7 | 2, 13 | 1, 9 |
| 95% for median | 2.3, 4.8 | 2.9, 6.4 | 1.7, 4.8 |
| Visit of earliest best response | |||
| Cycle 2, n (%) | 2 (22) | 1 (7) | 1 (9) |
| 95% CI for C2 percentage | 2.8, 60.0 | 0.2, 33.9 | 0.2, 41.3 |
| Cycle 4, n (%) | 3 (33) | 8 (57) | 7 (64) |
| 95% CI for C4 percentage | 7.5, 70.1 | 28.9, 82.3 | 30.8, 89.1 |
| Cycle 7, n (%) | 1 (11) | 4 (29) | 2 (18) |
| 95% CI for C7 percentage | 0.3, 48.2 | 8.4, 58.1 | 2.3, 51.8 |
| Cycle 10, n (%) | 2 (22) | 1 (7) | 1 (9) |
| 95% CI for C10 percentage | 2.8, 60.0 | 0.2, 33.9 | 0.2, 41.3 |
| Cycle 16, n (%) | 1 (11) | — | — |
| 95% CI for C16 percentage | 0.3, 48.2 | — | — |
| . | CR no PD no EOS and no New treatment (N = 9) . | CR with PD or death due to disease (N = 14) . | All other CR (N = 11) . |
|---|---|---|---|
| Age in years | |||
| Median | 27.0 | 41.0 | 28.0 |
| Range | 15, 63 | 21, 51 | 20, 54 |
| 95% CI for median | 20.6, 45.0 | 32.4, 44.2 | 23.8, 37.5 |
| Sex | |||
| Male, n (%) | 5 (56) | 4 (29) | 2 (18) |
| 95% CI for male percentage | 21.2, 86.3 | 8.4, 58.1 | 2.3, 51.8 |
| Female, n (%) | 4 (44) | 10 (71) | 9 (82) |
| 95% CI for male percentage | 13.7, 78.8 | 41.9, 91.6 | 48.2, 97.7 |
| ECOG performance status | |||
| Grade 0, n (%) | 5 (56) | 8 (57) | 5 (45) |
| 95% CI for ECOG 0 percentage | 21.2, 86.3 | 28.9, 82.3 | 16.7, 76.6 |
| Grade 1, n (%) | 4 (44) | 6 (43) | 6 (55) |
| 95% CI for ECOG 1 percentage | 13.7, 78.8 | 17.7, 71.1 | 23.4, 83.3 |
| Disease status relative to most recent prior therapy* | |||
| Relapse, n (%) | 6 (67) | 8 (57) | 9 (82) |
| 95% CI for relapse percentage | 29.9, 92.5 | 28.9, 82.3 | 48.2, 97.7 |
| Refractory, n (%) | 3 (33) | 6 (43) | 2 (18) |
| 95% CI for refractory percentage | 7.5, 70.1 | 17.7, 71.1 | 2.3, 51.8 |
| Primary refractory disease, n (%)† | 6 (67) | 9 (64) | 9 (82) |
| 95% CI for percentage | 54.1, 100.0 | 66.4, 100.0 | 66.4, 100.0 |
| Stage | |||
| Stage I/II, n (%) | 7 (78) | 9 (64) | 8 (73) |
| 95% for I/II percentage | 40.0, 97.2 | 35.1, 87.2 | 39.0, 94.0 |
| Stage III | 1 (11) | 2 (14) | 2 (18) |
| 95% CI for III percentage | 0.3, 48.2 | 1.8, 42.8 | 2.3, 51.8 |
| Stage IV | 1 (11) | 2 (14) | 1 (9) |
| 95% CI for IV percentage | 0.3, 48.2 | 1.8, 42.8 | 0.2, 41.3 |
| Median time in months from initial diagnosis to first dose (range) | −37.5 (-98.7, −16.4) | −45.8 (-184.7, −14.4) | −29.7 (-134.6, −21.0) |
| 95% CI | −67.9, −27.3 | −90.5, −35.3 | −66.7, −21.3 |
| Median time in months from most recent relapse to first dose (range)‡ | −1.3 (-5.6, −1.1) | −3.0 (-4.0, −0.9) | −2.3 (-8.5, −0.7) |
| 95% CI | −4.9, −0.3 | −3.7, −1.7 | −6.2, −1.4 |
| Median SPD (cm2) per investigator (range) | 11.3 (2.0, 55.2) | 18.4 (2.5, 59.0) | 16.7 (4.0, 116.1) |
| 95% CI | 4.4, 41.2 | 13.3, 33.8 | 4.5, 46.3 |
| Extranodal status, n (%)§ | |||
| No | 4 (44) | 9 (64) | 5 (45) |
| 95% for No percentage | 13.7, 78.8 | 35.1, 87.2 | 16.7, 76.6 |
| Yes | 5 (56) | 5 (36) | 6 (55) |
| 95% for Yes percentage | 21.2, 86.3 | 12.8, 64.9 | 23.4, 83.3 |
| Number of prior cancer-related systemic therapy regimens¶ | |||
| Median | 4.0 | 3.5 | 2.0 |
| Range | 2, 7 | 2, 13 | 1, 9 |
| 95% for median | 2.3, 4.8 | 2.9, 6.4 | 1.7, 4.8 |
| Visit of earliest best response | |||
| Cycle 2, n (%) | 2 (22) | 1 (7) | 1 (9) |
| 95% CI for C2 percentage | 2.8, 60.0 | 0.2, 33.9 | 0.2, 41.3 |
| Cycle 4, n (%) | 3 (33) | 8 (57) | 7 (64) |
| 95% CI for C4 percentage | 7.5, 70.1 | 28.9, 82.3 | 30.8, 89.1 |
| Cycle 7, n (%) | 1 (11) | 4 (29) | 2 (18) |
| 95% CI for C7 percentage | 0.3, 48.2 | 8.4, 58.1 | 2.3, 51.8 |
| Cycle 10, n (%) | 2 (22) | 1 (7) | 1 (9) |
| 95% CI for C10 percentage | 2.8, 60.0 | 0.2, 33.9 | 0.2, 41.3 |
| Cycle 16, n (%) | 1 (11) | — | — |
| 95% CI for C16 percentage | 0.3, 48.2 | — | — |
The categories of CR no PD no EOS No new treatment and Known PD per INV or death due to disease exclude patients with consolidative stem cell transplant. Patients with consolidative stem cell transplant are included in the All other CR column. ECOG, Eastern Cooperative Oncology Group; PD, progressive disease; SPD, sum of the products of diameters.
Relapse = best response of CR or PR to most recent prior therapy; Refractory = best response of SD or PD to most recent prior therapy.
No CR or relapse within 3 months of frontline therapy.
For those with relapsed disease status to most recent prior therapy.
Extranodal lesions identified by the investigator as either index or non-index lesions at the baseline assessment.
Includes chemotherapy given for stem cell mobilization.