TABLE 2.
Disease response per RECIST v1.1 by independent review committee in evaluable patients with PD‐L1+ urothelial carcinoma
| Response category | All patients (N = 104) | Sensitivity analysis (n = 87) |
|---|---|---|
| Best overall response, n (%) | ||
| Complete response | 10 (10) | 10 (11) |
| Partial response | 15 (14) | 15 (17) |
| Stable disease | 15 (14) | 15 (17) |
| Progressive disease | 47 (45) | 47 (54) |
| Not evaluable for response | 17 (16) | 0 |
| Objective response rate, % (95% CI) | 24 (16, 33) | 29 (20, 39) |
| Disease control rate, % (95% CI) | 38 (29, 49) | 46 (35, 57) |
| Clinical benefit rate, % (95% CI) | 29 (20, 39) | 34.5 (25, 45) |
Objective response rate was the proportion of patients who had confirmed complete response or partial response using RECIST v1.1; disease control rate was the proportion of patients who achieved complete response or partial response or stable disease using RECIST v1.1; clinical benefit rate was defined as patients with complete response or partial response or ≥ 24 wk of stable disease.
Abbreviations: CI, confidence interval; PD‐L1+, programmed death ligand 1 positive; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1.