Table 1.
Enadenotucirev monotherapy | Enadenotucirev plus paclitaxel | All patients (N=38) | |||
Characteristic | 1×1012 IP (n=7) | 6×1012 IP (n=3) | 1×1012 IP (n=8) | 1×1012 IV (n=20) | |
Median age, years (min, max) | 68 (54, 77) | 64 (47, 68) | 60 (53, 70) | 59 (36, 76) | 63 (36, 77) |
ECOG performance status | |||||
0–1 | 6 (86) | 3 (100) | 7 (88) | 20 (100) | 36 (95) |
2 | 0 | 0 | 1 (13)* | 0 | 1 (3) |
Missing | 1 (14) | 0 | 0 | 0 | 1 (3) |
Median time from diagnosis to screening, months (min, max) | 42.8 (13.7, 90.9) | 28.0 (14.9, 50.0) | 50.6 (33.9, 109.7) | 39.0 (7.2, 278.7) | 41.8 (7.2, 278.7) |
Histological type | |||||
Serous adenocarcinoma | 4 (57) | 3 (100) | 5 (63) | 15 (75) | 27 (71) |
Endometrioid adenocarcinoma | 1 (14) | 0 | 0 | 1 (5) | 2 (5) |
Other | 2 (29) | 0 | 3 (38) | 4 (20) | 9 (24) |
Median (min, max) CA-125 (U/mL) | 8750 (93, 29520) | 114 (108, 120) | 362 (135, 12000) | 138 (30, 3958) | 151 (30, 29520) |
n | 3 | 2 | 7 | 17 | 29 |
Median (min, max) prior regimens | 6 (3, 6) | 4 (2, 6) | 6 (4, 8) | 4 (1, 12) | 5 (1, 12) |
Prior chemotherapy | 7 (100) | 3 (100) | 8 (100) | 20 (100) | 38 (100) |
Prior paclitaxel | 7 (100) | 3 (100) | 8 (100) | 20 (100) | 38 (100) |
Prior hormonal therapy | 2 (29) | 1 (33) | 2 (25) | 4 (20) | 9 (24) |
Prior monoclonal antibodies | 1 (14) | 1 (33) | 6 (75)† | 13 (65) | 21 (55) |
Prior bevacizumab | 1 (14) | 1 (33) | 6 (75) | 12 (60) | 20 (53) |
Prior ipilimumab | 0 | 0 | 1 (13) | 0 | 1 (3) |
Prior nivolumab | 0 | 0 | 1 (13) | 0 | 1 (3) |
Other | 0 | 0 | 0 | 1 (5) | 1 (3) |
Prior cancer-related surgery | 7 (100) | 3 (100) | 8 (100) | 17 (85) | 35 (92) |
Interval from last taxane-based chemotherapy | |||||
<6 months | 1 (14) | 3 (100) | 0 | 4 (20) | 8 (21) |
≥6 months | 6 (86) | 0 | 8 (100) | 16 (80) | 30 (79) |
Data are n (%) unless specified otherwise.
*One patient had and ECOG performance status of 1 at screening and two at baseline.
†One patient received prior bevacizumab, ipilimumab, and nivolumab.
ECOG, Eastern Oncology Cooperative Group; IP, intraperitoneal; IV, intravenous.