Table 1 Demographic and baseline characteristics of the participants in the full analysis set
Suvemcitug plus chemotherapy (n = 281) | Placebo plus chemotherapy (n = 140) | P value# | |
|---|---|---|---|
Age, years | 0.9999 | ||
Median age (range) | 56.0 (36–76) | 55.0 (34–79) | |
>65 | 38 (13.5) | 20 (14.3) | |
Ethnic groups | 0.873 | ||
Han Chinese | 266 (94.7) | 132 (94.3) | |
Other | 15 (5.3) | 8 (5.7) | |
Origin of cancer | 0.014 | ||
Epithelial OC | 263 (93.6) | 120 (85.7) | |
Fallopian tube cancer | 15 (5.3) | 19 (13.6) | |
Primary peritoneal cancer | 3 (1.1) | 1 (0.7) | |
ECOG performance status score† | 0.063 | ||
0 | 106 (37.7) | 40 (28.6) | |
1 | 175 (62.3) | 100 (71.4) | |
Histologic diagnosis | 0.176 | ||
High-grade serous adenocarcinoma | 278 (98.9) | 136 (97.1) | |
Endometrioid carcinoma | 3 (1.1) | 4 (2.9) | |
Sum of the target lesion diameter, median (range), mm | 41.20 (10.0–322.8) | 43.05 (10.7–229.1) | 0.495 |
FIGO stage | 0.901 | ||
I | 7 (2.5) | 4 (2.9) | |
II | 13 (4.6) | 9 (6.4) | |
III | 195 (69.4) | 95 (67.9) | |
IV | 62 (22.1) | 31 (22.1) | |
Unknown | 4 (1.4) | 1 (0.7) | |
Confirmed distant metastasis | |||
Peritoneum | 160 (56.9) | 79 (56.4) | 0.923 |
Lymph node | 181 (64.4) | 78 (55.7) | 0.084 |
Pelvic cavity | 98 (34.9) | 53 (37.9) | 0.548 |
Liver | 86 (30.6) | 39 (27.9) | 0.561 |
Lungs | 22 (7.8) | 16 (11.4) | 0.225 |
Spleen | 26 (9.3) | 13 (9.3) | 0.991 |
Bone | 9 (3.2) | 4 (2.9) | 0.847 |
Kidney | 0 | 2 (1.4) | 0.045 |
Other | 151 (53.7) | 81 (57.9) | 0.423 |
Previous lines of systemic therapy | 0.812 | ||
1 | 87 (31.0) | 40 (28.6) | |
2 | 106 (37.7) | 52 (37.1) | |
3 | 59 (21.0) | 35 (25.0) | |
≥4 | 29 (10.3) | 13 (9.3) | |
Platinum-free interval, months | 0.369 | ||
<1 | 29 (10.3) | 21 (15.0) | |
1–3 | 81 (28.8) | 37 (26.4) | |
≥3 | 171 (60.9) | 82 (58.6) | |
Previous chemotherapy | |||
Platinum-based drugs | 281 (100) | 140 (100) | - |
Taxanes | 279 (99.3) | 138 (98.6) | 0.475 |
Anthracyclines | 71 (25.3) | 23 (16.4) | 0.040 |
Topoisomerase 1 inhibitors | 4 (1.4) | 2 (1.4) | 0.997 |
Other | 49 (17.4) | 24 (17.1) | 0.940 |
Chemotherapeutic agents | 0.998 | ||
Paclitaxel | 124 (44.1) | 62 (44.3) | |
PEGylated liposomal doxorubicin | 88 (31.3) | 44 (31.4) | |
Topotecan | 69 (24.6) | 34 (24.3) | |
Previous antiangiogenic therapy | 0.972 | ||
Yes | 139 (49.5) | 69 (49.3) | |
No | 142 (50.5) | 71 (50.7) | |
Previous bevacizumab therapy | 123 (43.8) | 61 (43.6) | 0.969 |
Previous PARP inhibitor therapy | 138 (49.1) | 70 (50.0) | 0.863 |
Ascites | 0.981 | ||
Yes | 92 (32.7) | 46 (32.9) | |
No | 189 (67.3) | 94 (67.1) | |
Pleural effusion | 0.634 | ||
Yes | 26 (9.3) | 11 (7.9) | |
No | 255 (90.7) | 129 (92.1) | |
CA-125 | 0.597 | ||
≤2 × ULN | 36 (12.8) | 14 (10.0) | |
2 × ULN–1,000 | 178 (63.3) | 95 (67.9) | |
>1,000 | 67 (23.8) | 31 (22.1) | |
Platinum-refractory | 0.713 | ||
No | 256 (91.1) | 126 (90.0) | |
Number of prior systemic therapies ‡ | 0.807 | ||
1 | 190 (67.6) | 93 (66.4) | |
2 | 91 (32.4) | 47 (33.6) |
