Table 4 Safety summary
n (%) | KN046 3 mg/kg Q2W + nab-paclitaxel (n = 16) | KN046 5 mg/kg Q2W + nab-paclitaxel (n = 11) | Total (n = 27) |
|---|---|---|---|
TEAE | 16 (100.0%) | 11 (100.0%) | 27 (100.0%) |
TEAE associated with any study drug | 16 (100.0%) | 11 (100.0%) | 27 (100.0%) |
TEAE Grade ≥ 3 | 11 (68.8%) | 7 (63.6%) | 18 (66.7%) |
TEAE Grade ≥ 3 associated with any study drug | 11 (68.8%) | 7 (63.6%) | 18 (66.7%) |
SAE | 6 (37.5%) | 3 (27.3%) | 9 (33.3%) |
SAE associated with any study drug | 4 (25.0%) | 2 (18.2%) | 6 (22.2%) |
irAE | 8 (50.0%) | 5 (45.5%) | 13 (48.1%) |
irAE Grade ≥ 3 | 0 | 3 (27.3%) | 3 (11.1%) |
Immune-related SAE | 0 | 1 (9.1%) | 1 (3.7%) |
TEAE leading to any treatment withdrawal | 6 (37.5%) | 3 (27.3%) | 9 (33.3%) |
TEAE leading to death | 2 (12.5%) | 0 | 2 (7.4%) |
TEAE leading to death associated with KN046 | 0 | 0 | 0 |
