Table 2.
Sugemalimab-related adverse events reported in > 10% patients and any ≥ grade 3 sugemalimab-related adverse events in dose-expansion phase 1b (N = 178)
| Preferred term | Any grade | Grade 3–5 | ||
|---|---|---|---|---|
| Sugemalimab monotherapy cohorts (N = 69) | Sugemalimab in combination with chemotherapy cohorts (N = 109) | Sugemalimab monotherapy cohorts (N = 69) | Sugemalimab in combination with chemotherapy cohorts (N = 109) | |
| Number of patients with at least one sugemalimab-related AEs, n (%) | 58 (84.1) | 101 (92.7) | 11 (15.9) | 44 (40.4) |
| Anemia | 13 (18.8) | 43 (39.4) | 2 (2.8) | 12 (11.0) |
| Platelet count decreased | 5 (7.2) | 27 (24.8) | 0 | 9 (8.3) |
| White blood cell count decreased | 5 (7.2) | 27 (24.8) | 0 | 8 (7.3) |
| Neutrophil count decreased | 4 (5.8) | 24 (22.0) | 0 | 9 (8.3) |
| AST increased | 16 (23.2) | 22 (20.2) | 0 | 1 (0.9) |
| Rash | 2 (2.9) | 18 (16.5) | 0 | 0 |
| ALT increased | 15 (21.7) | 17 (15.6) | 1 (1.4) | 1 (0.9) |
| Blood corticotrophin increased | 2 (2.9) | 16 (14.7) | 0 | 0 |
| Amylase increased | 6 (8.7) | 14 (12.8) | 0 | 4 (3.7) |
| Decreased appetite | 1 (1.4) | 14 (12.8) | 0 | 0 |
| Lymphocyte count decreased | 0 | 13 (11.9) | 0 | 2 (1.8) |
| Asthenia | 4 (5.8) | 13 (11.9) | 0 | 2 (1.8) |
| Thrombocytopenia | 0 | 10 (9.2) | 0 | 4 (3.7) |
| Gamma-glutamyltransferase increased | 0 | 10 (9.2) | 0 | 2 (1.8) |
| Hypothyroidism | 6 (8.7) | 10 (9.2) | 0 | 1 (0.9) |
| Hypertriglyceridaemia | 1 (1.4) | 10 (9.2) | 0 | 1 (0.9) |
| Proteinuria | 9 (13.0) | 10 (9.2) | 0 | 0 |
| Fatigue | 1 (1.4) | 9 (8.3) | 0 | 3 (2.8) |
| Hypomagnesaemia | 0 | 8 (7.3) | 0 | 1 (0.9) |
| Blood creatinine increased | 1 (1.4) | 8 (7.3) | 0 | 1 (0.9) |
| Bilirubin conjugated increased | 7 (10.1) | 8 (7.3) | 0 | 1 (0.9) |
| Neutropenia | 1 (1.4) | 7 (6.4) | 0 | 2 (1.8) |
| Blood bilirubin increased | 7 (10.1) | 7 (6.4) | 0 | 1 (0.9) |
| Hyperthyroidism | 6 (8.7) | 7 (6.4) | 1 (1.4) | 0 |
| Hyponatraemia | 2 (2.9) | 6 (5.5) | 2 (2.9) | 3 (2.8) |
| Vomiting | 2 (2.9) | 6 (5.5) | 1 (1.4) | 1 (0.9) |
| Hepatic function abnormal | 2 (2.9) | 6 (5.5) | 1 (1.4) | 1 (0.9) |
| Pneumonia | 1 (1.4) | 6 (5.5) | 1 (1.4) | 0 |
| Bone marrow failure | 0 | 4 (3.7) | 0 | 3 (2.8) |
| Blood creatine phosphokinase increased | 4 (5.8) | 4 (3.7) | 1 (1.4) | 0 |
| Blood alkaline phosphatase increased | 4 (5.8) | 2 (1.8) | 0 | 1 (0.9) |
| Visual impairment | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Pneumonitis | 1 (1.4) | 1 (0.9) | 1 (1.4) | 1 (0.9) |
| Hepatitis | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Febrile neutropenia | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Death | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Cerebral hemorrhage | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Blood pressure increased | 0 | 1 (0.9) | 0 | 1 (0.9) |
| Pancytopenia | 1 (1.4) | 0 | 1 (1.4) | 0 |
| Myositis | 1 (1.4) | 0 | 1 (1.4) | 0 |
AE, adverse event