Summary of efficacy in the ITT population
| . | Brentuximab vedotin (n = 64) . | Physician’s choice (n = 64) . | P . |
|---|---|---|---|
| ORR4 per IRF, n (%) | 35 (54.7)* | 8 (12.5) | <.001 |
| Best response per IRF, n (%) | |||
| ORR (CR+PR) | 42 (65.6) | 13 (20.3) | <.001 |
| CR | 11 (17.2) | 1 (1.6) | .002 |
| PR | 31 (48.4) | 12 (18.8) | |
| SD | 10 (15.6) | 18 (28.1) | |
| PD | 5 (7.8) | 22 (34.4) | |
| Median PFS per IRF, months (95% CI)† | 16.7 (15.4-21.6) | 3.5 (2.4-4.6) | |
| HR for PFS (95% CI) | 0.38 (0.25-0.58) | <.001 | |
| 3-y OS rate, % (95% CI) | 64.4 (50.7-75.2) | 61.9 (47.3-73.6)‡ | |
| HR for OS (95% CI) | 0.75 (0.42-1.32) | .310 | |
| . | Brentuximab vedotin (n = 64) . | Physician’s choice (n = 64) . | P . |
|---|---|---|---|
| ORR4 per IRF, n (%) | 35 (54.7)* | 8 (12.5) | <.001 |
| Best response per IRF, n (%) | |||
| ORR (CR+PR) | 42 (65.6) | 13 (20.3) | <.001 |
| CR | 11 (17.2) | 1 (1.6) | .002 |
| PR | 31 (48.4) | 12 (18.8) | |
| SD | 10 (15.6) | 18 (28.1) | |
| PD | 5 (7.8) | 22 (34.4) | |
| Median PFS per IRF, months (95% CI)† | 16.7 (15.4-21.6) | 3.5 (2.4-4.6) | |
| HR for PFS (95% CI) | 0.38 (0.25-0.58) | <.001 | |
| 3-y OS rate, % (95% CI) | 64.4 (50.7-75.2) | 61.9 (47.3-73.6)‡ | |
| HR for OS (95% CI) | 0.75 (0.42-1.32) | .310 | |
PD, progressive disease; PR, partial response; SD, stable disease.
Based on additional information provided to the IRF after the 31 May 2016 data cutoff, the IRF determined that 1 patient had not achieved ORR4 as was originally reported; the change in status was determined through a standard IRF adjudication process.
Median follow-up for OS in the brentuximab vedotin arm was 48.4 mo.
Median follow-up for OS in the physician’s choice arm was 42.9 mo.