Table 1 –
Baseline demographic and clinical characteristics in patients with CPS ≥1 and CPS <1 (among all randomized patients with quantifiable CPS and TC at baseline)
| CPS ≥1 | CPS <1 | |||
|---|---|---|---|---|
| Nivolumab (N = 281) |
Placebo (N = 276) |
Nivolumab (N = 34) |
Placebo (N = 38) |
|
| Age | ||||
| Median (range), years | 66.0 (33–92) | 67.0 (42–88) | 66.5 (34–83) | 66.9 (47–81) |
| Male sex, n (%) | 214 (76) | 211 (76) | 23 (68) | 29 (76) |
| Race or ethnic group, n (%) a | ||||
| White | 236 (84) | 234 (85) | 25 (74) | 33 (87) |
| Asian | 39 (14) | 33 (12) | 6 (18) | 5 (13) |
| Black | 1 (0.36) | 3 (1.1) | 1 (2.9) | 0 |
| Other | 5 (1.8) | 5 (1.8) | 2 (5.9) | 0 |
| ECOG PS, n (%) a | ||||
| 0 | 180 (64) | 176 (64) | 23 (68) | 23 (61) |
| 1 | 95 (34) | 90 (33) | 11 (32) | 15 (39) |
| 2 | 6 (2.1) | 9 (3.3) | 0 | 0 |
| Tumor origin at initial diagnosis, n (%) | ||||
| Urinary bladder | 236 (84) | 222 (80) | 19 (56) | 26 (68) |
| Renal pelvis | 25 (8.9) | 32 (12) | 9 (26) | 11 (30) |
| Ureter | 20 (7.1) | 22 (8.0) | 6 (18) | 1 (2.6) |
| Minor histological variants present, n (%) | 122 (43) | 121 (44) | 14 (41) | 8 (21) |
| Less than 1 year from initial disease diagnosis to randomization, n (%) | 260 (93) | 251 (91) | 32 (94) | 35 (92) |
| Tumor cell PD-L1 expression of ≥1%, n (%) | 124 (44) | 124 (45) | 0 | 1 (2.6) |
| Previous cisplatin-based therapy, n (%) | 133 (47) | 126 (46) | 12 (35) | 20 (53) |
| Pathologic tumor stage at resection, n (%) b | ||||
| pTX | 5 (1.8) | 0 | 0 | 0 |
| pT0 | 4 (1.4) | 7 (2.5) | 0 | 0 |
| pTis | 3 (1.1) | 2 (0.72) | 0 | 1 (2.6) |
| pT1 | 7 (2.5) | 10 (3.6) | 5 (15) | 2 (5.3) |
| pT2 | 56 (20) | 53 (19) | 3 (8.8) | 9 (24) |
| pT3 | 158 (56) | 161 (58) | 23 (68) | 17 (45) |
| pT4 | 48 (17) | 42 (15) | 2 (5.9) | 9 (24) |
| Nodal status at resection, n (%) c | ||||
| N0 or NX with <10 nodes removed | 64 (23) | 72 (26) | 15 (44) | 12 (32) |
| N0 with ≥10 nodes resected | 80 (28) | 65 (24) | 3 (8.8) | 8 (21) |
| N1 | 57 (20) | 56 (20) | 4 (12) | 7 (18) |
| N2 | 68 (24) | 66 (24) | 12 (35) | 7 (18) |
| N3 | 11 (3.9) | 17 (6.2) | 0 | 3 (7.9) |
a
Not reported for one patient in the placebo arm with CPS ≥1.
b
Not reported for one patient in the placebo arm with CPS ≥1 and one patient in the nivolumab arm with CPS <1.
c
Not reported for one patient in the nivolumab arm with CPS ≥1 and one patient in the placebo arm with CPS <1.
CPS, combined positive score; ECOG PS, Eastern Cooperative Oncology Group performance status; N, node; p, pathologic; PD-L1, programmed death ligand 1; T, tumor; TC, tumor cell score; Tis, tumor in situ; X, cannot be assessed.