Table 5.
Activity and safety of brentuximab vedotin in HL patients after alloSCT compared with HL patients in the pivotal trial
| Post-alloSCT patients (n = 25) | Pivotal trial (n = 102)*21 | |
|---|---|---|
| Measures of response† | ||
| Objective response, % | 50 | 75 |
| CR, % | 38 | 34 |
| Disease control, %‡ | 92 | 96 |
| PFS, mo, median | 7.8 | 5.6 |
| Range | 0.5-12.2+ | NA |
| 95% CI | NA | 5.0-9.0 |
| Time to objective response, wks, median (range)§ | 8.1 (5.3-32) | 5.7 (5.1-56) |
| Patients with CR | ||
| No. (%) of patients | 9 (38) | 35 (34) |
| Time to CR, wks, median (range)§ | 10.7 (6.3-32) | 12 (5.1-56) |
| Safety | ||
| Adverse events of at least grade 3, % | 72 | 55 |
| Adverse events leading to treatment discontinuation, % | 36 | 20 |
| Most common treatment-related adverse events, %¶ | ||
| Peripheral sensory neuropathy | 48 | 42 |
| Nausea | 28 | 35 |
| Alopecia | 24 | 10 |
| Neutropenia | 24 | 19 |
| Fatigue | 20 | 34 |
| Vomiting | 20 | 13 |
95% CI indicates 95% confidence interval; and NA, not available.
*
Patients who had previously received an alloSCT were excluded from participation in the pivotal trial.
†
Efficacy results for the post-alloSCT patients in this series (24 efficacy evaluable) were based on investigator judgment, whereas those for the pivotal trial were determined by an independent radiology review facility.
‡
CR + PR + stable disease.
§
Restaging per institutional standard of care in this series could have affected the time to response data.
¶
Considered by the investigator to be related to brentuximab vedotin.