Table 1:

Baseline characteristics

	All participants (n=249)
Age (years)	68 (63–76)
Age category
<65 years	78 (31%)
≥65 years	171 (69%)
Sex
Male	178 (72%)
Female	71 (29%)
Race or ethnic group
White	195 (78%)
Black or African American	11 (4%)
Asian	17 (7%)
Native Hawaiian or other Pacific Islander	2 (1%)
Other	24 (10%)
Geographical region
USA	174 (70%)
Europe	63 (25%)
Asia	12 (5%)
ECOG performance status
0	88 (35%)
1	161 (65%)
Subsite of tumour
Upper tract (renal pelvis or ureter)	58 (23%)
Lower tract (bladder or urethra)	191 (77%)
Visceral metastasis
Present	210 (84%)
Absent	39 (16%)
Albumin concentration*
<35 g/L	45 (18%)
≥35 g/L	197 (79%)
Haemoglobin concentration*
<100 g/L	41 (16%)
≥100 g/L	201 (81%)
Smoking history
Never smoked	88 (35%)
Ever smoked	161 (65%)
Time since first diagnosis (months)	20 4 (1 9–289 2)
Time since diagnosis of metastatic disease (months)	11 8 (0 6–70 7)
Number of previous anticancer lines for locally advanced or metastatic disease
≤1	119 (48%)
2	72 (29%)
≥3	52 (21%)
Median	2 0 (1 0–2 0)
PD-L1 expression status, ≥5% cutoff†
PD-L1-positive	82 (33%)
PD-L1-negative	124 (50%)
Bellmunt risk score‡
0	58 (23%)
1	114 (46%)
2	59 (24%)
3	18 (7%)
Eligibility status for platinum-based therapy
Yes	236 (95%)
No	13 (5%)

Data are median (IQR) or n (%). ECOG= Eastern Cooperative Oncology Group. PD-L1=programmed death ligand 1.

^*Baseline albumin and haemoglobin concentrations are reported for 242 post-platinum patients.

^†206 patients were evaluable for PD-L1 expression level; non-evaluable samples (n=43) were those that were missing, of poor quality due to insufficient tumour content or cellular preservation, or otherwise not available to provide results.

^‡Risk group 0 represents patients without any adverse prognostic factors (ie, ECOG performance status >0, haemoglobin concentration <100 g/L, and the presence of liver metastasis); risk groups 1–3 represent the presence of one, two, and three prognostic factors, respectively.⁴