Efficacy summary for patients enrolled in part D
| . | Anti–PD-(L)1–naive HL∗ (n = 21) . | Anti–PD-(L)1–progressed HL∗ (n = 20) . | DLBCL (n = 15) . |
|---|---|---|---|
| Follow-up, median (range), mo | 37.7 (1.2-54.5) | 39.1 (4.8-54.6) | 4.7 (0.6-53.5) |
| BOR, n (%) | |||
| CR | 4 (19) | 0 | 0 |
| PR | 9 (43) | 3 (15) | 1 (7) |
| SD | 6 (29) | 15 (75) | 2 (13) |
| PD | 0 | 1 (5) | 10 (67) |
| UTD† | 2 (10) | 1 (5) | 2 (13) |
| ORR, n (%), [95% CI] | 13 (62), [38.4-81.9] | 3 (15), [3.2-37.9] | 1 (7), [0.2-31.9] |
| DOR, median (95% CI), mo | 14.2 (2.6 to NR) | 6.4 (1.8 to NR) | NE |
| PFS, median (95% CI), mo | 19 (5.4 to NR) | 6 (3.7-10.0) | 2 (0.7-1.9) |
| OS | NE | NE | NE |
| . | Anti–PD-(L)1–naive HL∗ (n = 21) . | Anti–PD-(L)1–progressed HL∗ (n = 20) . | DLBCL (n = 15) . |
|---|---|---|---|
| Follow-up, median (range), mo | 37.7 (1.2-54.5) | 39.1 (4.8-54.6) | 4.7 (0.6-53.5) |
| BOR, n (%) | |||
| CR | 4 (19) | 0 | 0 |
| PR | 9 (43) | 3 (15) | 1 (7) |
| SD | 6 (29) | 15 (75) | 2 (13) |
| PD | 0 | 1 (5) | 10 (67) |
| UTD† | 2 (10) | 1 (5) | 2 (13) |
| ORR, n (%), [95% CI] | 13 (62), [38.4-81.9] | 3 (15), [3.2-37.9] | 1 (7), [0.2-31.9] |
| DOR, median (95% CI), mo | 14.2 (2.6 to NR) | 6.4 (1.8 to NR) | NE |
| PFS, median (95% CI), mo | 19 (5.4 to NR) | 6 (3.7-10.0) | 2 (0.7-1.9) |
| OS | NE | NE | NE |
Includes all response-evaluable patients. Responses were investigator-assessed. ORR per investigator was defined as CR + PR. PFS per investigator was defined as the time from first dose to the date of first objectively documented progression per the criteria relevant to each disease type or death due to any cause, whichever occurred first. OS was defined as the time between the date of the first dose and the date of death.
NE, not evaluable; OS, overall survival; PD, progressive disease; SD, stable disease; UTD, unable to determine.
Most patients had classic HL; 2 patients with nodular lymphocyte–predominant HL were included in part D (1 in PD-(L)1–progressed, with a BOR of SD, and 1 in PD-(L)1–naive, with a BOR of NE).
The reasons for response being UTD included death before disease assessment, NE, and other.