Table 1.
Patient demographics and disease characteristics
| Epacadostat + pembrolizumab (n = 44) |
Placebo + pembrolizumab (n = 49) | |
|---|---|---|
| Male, n (%) | 33 (75.0) | 38 (77.6) |
| Median age, years (range) | 74.0 (51–90) | 72.0 (50–88) |
| Age ≥ 65 years, n (%) | 35 (79.5) | 40 (81.6) |
| Race, n (%) | ||
| White | 33 (75.0) | 37 (75.5) |
| Asian | 9 (20.5) | 8 (16.3) |
| Unknown | 2 (4.5) | 4 (8.2) |
| ECOG performance status scorea | ||
| 0 | 8 (18.2) | 12 (24.5) |
| 1 | 15 (34.1) | 18 (36.7) |
| 2 | 21 (47.7) | 19 (38.8) |
| Disease status at screening, n (%) | ||
| Locally advanced/unresectable | 6 (13.6) | 4 (8.2) |
| Metastatic | 38 (86.4) | 45 (91.8) |
| Metastases location, n (%) | ||
| Visceral disease | 27 (61.4) | 35 (71.4) |
| Lymph node only | 12 (27.3) | 8 (16.3) |
| Neither visceral disease nor lymph node only | 5 (11.4) | 6 (12.2) |
| Liver metastases present, n (%) | 5 (11.4) | 11 (22.4) |
| Primary tumor location, n (%) | ||
| Upper tract | 8 (18.2) | 9 (18.4) |
| Lower tract | 36 (81.8) | 35 (71.4) |
| Unknown | 0 | 5 (10.2) |
| Prior neoadjuvant/adjuvant platinum-based chemotherapy, n (%) | 6 (13.6) | 6 (12.2) |
| Prior BCG therapy, n (%) | 2 (4.5) | 4 (8.2) |
| Bajorin risk score | ||
| 0 | 7 (15.9) | 9 (18.4) |
| 1 | 27 (61.4) | 25 (51.0) |
| 2 | 10 (22.7) | 15 (30.6) |
| PD-L1 status, n (%) | ||
| CPS ≥ 10 | 25 (56.8) | 27 (55.1) |
| CPS < 10 | 19 (43.2) | 22 (44.9) |
| Primary reason for cisplatin-ineligibility,b n (%) | ||
| ECOG performance status score ≥ 2 | 20 (45.5) | 15 (30.6) |
| Creatinine clearance < 60 mL/min | 13 (29.5) | 20 (40.8) |
| Grade ≥ 2 audiometric hearing loss | 3 (6.8) | 5 (10.2) |
| Grade ≥ 2 peripheral neuropathy | 2 (4.5) | 2 (4.1) |
| NYHA class III heart failure | 1 (2.3) | 2 (4.1) |
| Multiple reasons | 5 (11.4) | 4 (8.2) |
| Missing | 0 | 1 (2.0) |
BCG Bacillus Calmette-Guérin, CPS combined positive score, ECOG Eastern Cooperative Oncology Group, NYHA New York Heart Association, PD-L1 programmed death-ligand 1
aAssessed during screening
bAssessed by the study investigator during screening