Table 1.
Patient demographics and baseline characteristics, 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) | |
| Median age, years (range) | 58.0 (48–62) | 63.0 (48–70) | 65.5 (30–67) | 66.0 (39–69) | 63.0 (30–70) |
| Female, n (%) | 2 (66.7) | 2 (66.7) | 4 (66.7) | 2 (66.7) | 10 (66.7) |
| Race, n (%) | |||||
| White or Caucasian | 3 (100.0) | 3 (100.0) | 6 (100.0) | 2 (66.7) | 14 (93.3) |
| Asian | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (6.7) |
| ECOG performance status, n (%) | |||||
| 0 | 3 (100.0) | 1 (33.3) | 2 (33.3) | 3 (100.0) | 9 (60.0) |
| 1 | 0 (0.0) | 2 (66.7) | 4 (66.7) | 0 (0.0) | 6 (40.0) |
| PD-L1 status, n (%)a | |||||
| Positive | 0 (0.0) | 2 (66.7) | 2 (33.3) | 1 (33.3) | 5 (33.3) |
| Negative | 2 (66.7) | 1 (33.3) | 3 (50.0) | 2 (66.7) | 8 (53.3) |
| Missing | 1 (33.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 2 (13.3) |
| Metastatic sites, n (%) | |||||
| Lymph nodes | 3 (100.0) | 1 (33.3) | 5 (83.3) | 1 (33.3) | 10 (66.7) |
| Lung | 1 (33.3) | 1 (33.3) | 2 (33.3) | 1 (33.3) | 5 (33.3) |
| Peritoneum | 1 (33.3) | 1 (33.3) | 2 (33.3) | 1 (33.3) | 5 (33.3) |
| Liver | 0 (0.0) | 0 (0.0) | 3 (50.0) | 1 (33.3) | 4 (26.7) |
| Bone | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (66.7) | 3 (20.0) |
| Soft tissue | 2 (66.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (13.3) |
| Brain | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) |
| Muscle | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) |
| Otherb | 2 (66.7) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 4 (26.7) |
| Prior lines of systemic treatment, n (%)c | |||||
| 1 | 0 (0.0) | 1 (33.3) | 3 (50.0) | 2 (66.7) | 6 (40.0) |
| 2 | 2 (66.7) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 4 (26.7) |
| ≥3 | 1 (33.3) | 0 (0.0) | 2 (33.3) | 1 (33.3) | 4 (26.7) |
| Latest type of prior systemic treatment, n (%) | |||||
| Adjuvant | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (6.7) |
| Locally advanced | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (66.7) | 3 (20.0) |
| Metastatic | 3 (100.0) | 1 (33.3) | 5 (83.3) | 1 (33.3) | 10 (66.7) |
| (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) | |
| Median age, years (range) | 72.0 (48–76) | 69.5 (46–78) | 71.0 (46–78) |
| Female, n (%) | 7 (58.3) | 1 (8.3) | 8 (33.3) |
| Race, n (%) | |||
| White or Caucasian | 12 (100.0) | 10 (83.3) | 22 (91.7) |
| Native Hawaiian or other Pacific Islander | 0 (0.0) | 1 (8.3) | 1 (4.2) |
| Other | 0 (0.0) | 1 (8.3) | 1 (4.2) |
| ECOG performance status, n (%) | |||
| 0 | 6 (50.0) | 6 (50.0) | 12 (50.0) |
| 1 | 6 (50.0) | 6 (50.0) | 12 (50.0) |
| PD-L1 status, n (%)a | |||
| Positive | 4 (33.3) | 6 (50.0) | 10 (41.7) |
| Negative | 7 (58.3) | 6 (50.0) | 13 (54.2) |
| Missing | 1 (8.3) | 0 (0.0) | 1 (4.2) |
| Metastatic sites, n (%) | |||
| Lymph nodes | 6 (50.0) | 7 (58.3) | 13 (54.2) |
| Lung | 7 (58.3) | 3 (25.0) | 10 (41.7) |
| Liver | 7 (58.3) | 1 (8.3) | 8 (33.3) |
| Soft tissue | 4 (33.3) | 0 (0.0) | 4 (16.7) |
| Peritoneum | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| Bone | 1 (8.3) | 1 (8.3) | 2 (8.3) |
| Muscle | 0 (0.0) | 1 (8.3) | 1 (4.2) |
| Kidney | 0 (0.0) | 1 (8.3) | 1 (4.2) |
| Prior lines of systemic treatment, n (%)c | |||
| 1 | 4 (33.3) | 10 (83.3) | 14 (58.3) |
| 2 | 4 (33.3) | 1 (8.3) | 5 (20.8) |
| ≥3 | 1 (8.3) | 1 (8.3) | 2 (8.3) |
| Latest type of prior systemic treatment, n (%) | |||
| Adjuvant | 3 (25.0) | 4 (33.3) | 7 (29.2) |
| Locally advanced | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Metastatic | 6 (50.0) | 7 (58.3) | 13 (54.2) |
ECOG Eastern Cooperative Oncology Group, PD-L1 programmed death-ligand 1, UC urothelial carcinoma.
aThe PD-L1 assay was performed on tissue samples from the 39 subjects enroled. In Phase 1, 27 samples were archival samples and there were no fresh samples. In Phase 2, 11 samples were archival samples and 1 sample was a fresh.
b’Other’ includes ovaries (sigmoid deposit), pelvis, pleura, spleen and pancreas.
cMissing information for one patient in Phase 1a (BGB-A333 900 mg arm), and for three patients in the Phase 1b cohort.