Table 4.
Duration of response, Phase 1b and Phase 2, intent-to-treat population.
| Phase 1b BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | Phase 2 UC cohort BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | |
|---|---|---|
| Number of responders | 2 | 5 |
| Number of patients with events, n (%) | 0 (0.0) | 3 (60.0) |
| PD | 0 (0.0) | 3 (60.0) |
| Death | 0 (0.0) | 0 (0.0) |
| Number of patients censored, n (%) | 2 (100.0) | 2 (40.0) |
| DoR, months | ||
| Median (95% CI) | NE | 9.6 (6.0, NE) |
| Q1 (95% CI) | NE | 9.1 (6.0, 9.6) |
| Q3 (95% CI) | NE | NE (6.0, NE) |
| Event-free rate (95% CI) | ||
| 3 Month | 100.0 (NE, NE) | 100.0 (NE, NE) |
| 6 Month | 100.0 (NE, NE) | 100.0 (NE, NE) |
| 9 Month | 100.0 (NE, NE) | 80.0 (20.4, 96.9) |
| 12 Month | NE | NE |
DoR defined as time from first determination of an objective response per RECIST v1.1 [29] until the first documentation of disease progression or death, whichever occurred first.
CI confidence interval, DoR duration of response, NE not estimable, PD progressive disease, RECIST Response Evaluation Criteria in Solid Tumors, UC urothelial carcinoma.