Table 2.
Overview of treatment-emergent adverse events, intent-to-treat population, (A) Phase 1a; (B) Phase 1b and Phase 2.
| (A) | |||||
|---|---|---|---|---|---|
| BGB-A333 450 mg (n = 3) | BGB-A333 900 mg (n = 3) | BGB-A333 1350 mg (n = 6) | BGB-A333 1800 mg (n = 3) | Total (N = 15) | |
| Patients with at least one TEAE, n (%) | 1 (33.3) | 2 (66.7) | 6 (100.0) | 3 (100.0) | 12 (80.0) |
| Treatment-related TEAE | 1 (33.3) | 1 (33.3) | 4 (66.7) | 2 (66.7) | 8 (53.3) |
| Grade 3 and 4 TEAE, n (%)a | 0 (0.0) | 1 (33.3) | 3 (50.0) | 1 (33.3) | 5 (33.3) |
| Treatment-related ≥ Grade 3 TEAE | 0 (0.0) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 2 (13.3) |
| Serious TEAE, n (%) | 0 (0.0) | 1 (33.3) | 3 (50.0) | 1 (33.3) | 5 (33.3) |
| Treatment-related serious TEAE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| TEAE leading to death, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| TEAE leading to permanent treatment discontinuation, n (%) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (6.7) |
| TEAE leading to dose modification, n (%) | 0 (0.0) | 1 (33.3) | 3 (50.0) | 2 (66.7) | 6 (40.0) |
| TEAE leading to dose interruption | 0 (0.0) | 1 (33.3) | 3 (50.0) | 2 (66.7) | 6 (40.0) |
| Immune-mediated AE, n (%) | 0 (0.0) | 1 (33.3) | 2 (33.3) | 0 (0.0) | 3 (20.0) |
| Immune-mediated AE ≥ Grade 3 | 0 (0.0) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 2 (13.3) |
| Infusion-related reaction, n (%) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Infusion-related reaction ≥ Grade 3 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dose-limiting toxicity event, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| (B) | |||
|---|---|---|---|
| Phase 1b BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | Phase 2 UC cohort BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | Total (N = 24) | |
| Patients with at least one TEAE, n (%) | 12 (100.0) | 12 (100.0) | 24 (100.0) |
| Treatment-related TEAE | 7 (58.3) | 5 (41.7) | 12 (50.0) |
| BGB-A333-related TEAE | 6 (50.0) | 5 (41.7) | 11 (45.8) |
| Tislelizumab-related TEAE | 7 (58.3) | 5 (41.7) | 12 (50.0) |
| Grade ≥ 3 TEAE, n (%) | 7 (58.3) | 4 (33.3) | 11 (45.8) |
| Treatment-related ≥Grade 3 TEAE | 3 (25.0) | 2 (16.7) | 5 (20.8) |
| BGB-A333-related ≥Grade 3 TEAE | 3 (25.0) | 2 (16.7) | 5 (20.8) |
| Tislelizumab-related ≥Grade 3 TEAE | 3 (25.0) | 2 (16.7) | 5 (20.8) |
| Serious TEAE, n (%) | 5 (41.7) | 3 (25.0) | 8 (33.3) |
| Treatment-related serious TEAE | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| BGB-A333-related serious TEAE | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| Tislelizumab-related serious TEAE | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| TEAE leading to death, n (%) | 1 (8.3) | 1 (8.3) | 2 (8.3) |
| BGB-A333-related TEAE leading to death | 1 (8.3) | 0 (0.0) | 1 (4.2) |
| Tislelizumab-related TEAE leading to death | 1 (8.3) | 0 (0.0) | 1 (4.2) |
| TEAE leading to permanent treatment discontinuation, n (%) | 4 (33.3) | 2 (16.7) | 6 (25.0) |
| TEAE leading to dose modification, n (%) | 1 (8.3) | 2 (16.7) | 3 (12.5) |
| TEAE leading to dose interruption | 1 (8.3) | 2 (16.7) | 3 (12.5) |
| TEAE leading to dose reduction | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Immune-mediated AE, n (%) | 3 (25.0) | 2 (16.7) | 5 (20.8) |
| Immune-mediated AE ≥ Grade 3 | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| Infusion-related reaction, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Infusion-related reaction ≥Grade 3 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dose-limiting toxicity event, n (%) | 1 (8.3) | 0 (0.0) | 1 (4.2) |
AE adverse event, TEAE treatment-emergent adverse event, UC urothelial carcinoma.
aNo Grade 5 TEAEs occurred in Phase 1a.