TABLE 1.
Patient demographics and baseline clinical characteristics of the Japanese subgroup (intention‐to‐treat population)
| Parameter/characteristic | Enfortumab vedotin (n = 36) | Standard chemotherapy (n = 50) |
|---|---|---|
| Age, years | ||
| Mean (SD) | 69.86 (5.93) | 67.06 (9.07) |
| Median (range) | 70.00 (58.0, 81.0) | 66.50 (44.0, 87.0) |
| Age category (years), n (%) | ||
| <65 | 7 (19.4) | 22 (44.0) |
| 65 to <75 | 22 (61.1) | 17 (34.0) |
| ≥75 | 7 (19.4) | 11 (22.0) |
| Sex, n (%) | ||
| Male | 28 (77.8) | 36 (72.0) |
| Female | 8 (22.2) | 14 (28.0) |
| Tobacco use, n (%) | ||
| Former user | 24 (66.7) | 30 (60.0) |
| Current user | 2 (5.6) | 3 (6.0) |
| Never used | 10 (27.8) | 16 (32.0) |
| Not reported | 0 | 1 (2.0) |
| History of diabetes/hyperglycemia, n (%) | 5 (13.9) | 9 (18.0) |
| ECOG performance status, n (%) | ||
| 0 | 30 (83.3) | 31 (62.0) |
| 1 | 6 (16.7) | 19 (38.0) |
| Bellmunt risk score, n (%) | ||
| 0–1 | 33 (91.7) | 36 (72.0) |
| ≥2 | 3 (8.3) | 14 (28.0) |
| Primary tumor site, n (%) | ||
| Upper tract (renal pelvis, ureter) | 22 (61.1) | 25 (50.0) |
| Bladder/other | 14 (38.9) | 25 (50.0) |
| Sites of metastasis, n (%) | ||
| Lymph node only | 3 (8.3) | 5 (10.2) |
| Visceral site | 30 (83.3) | 40 (81.6) |
| Liver metastasis | 5 (13.9) | 11 (22.0) |
| Histology type at diagnosis, n (%) | ||
| UC/transitional cell | 36 (100) | 44 (88.0) |
| UC mixed | 0 | 5 (10.0) |
| Other | 0 | 1 (2.0) |
| Previous systemic therapies, n (%) | ||
| 1–2 | 28 (77.8) | 44 (88.0) |
| ≥3 | 8 (22.2) | 6 (12.0) |
| Type of prior platinum‐based treatment received, n (%) | ||
| Cisplatin‐based only | 22 (61.1) | 32 (64.0) |
| Carboplatin‐based only | 7 (19.4) | 10 (20.0) |
| Both cisplatin‐based and carboplatin‐based | 7 (19.4) | 7 (14.0) |
| Median time since diagnosis of metastatic or locally advanced disease (range), mo | 18.3 (0.4, 46.0) | 13.3 (0.7, 53.8) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; SD, standard deviation; UC, urothelial carcinoma.