Table 3.
Summary of adverse events for all patients who received treatment (safety set).
| Event | AK112 (10 mg/kg Q3W) plus chemotherapy (n = 40) |
AK112 (20 mg/kg Q3W) plus chemotherapy (n = 43) |
Total (n = 83) |
|||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Any treatment-emergent adverse events | 40 (100.0) | 21 (52.5) | 43 (100.0) | 22 (51.2) | 83 (100.0) | 43 (51.8) |
| Adverse event leading to discontinuation of study drug | 1 (2.5) | 1 (2.3) | 2 (2.4) | |||
| Adverse event leading to death | 1 (2.5) | 4 (9.3) | 5 (6.0) | |||
| Any treatment-related adverse events | 37 (92.5) | 9 (22.5) | 39 (90.7) | 13 (30.2) | 76 (91.6) | 22 (26.5) |
| Any treatment-related adverse event leading to discontinuation of the study drug | 1 (2.5) | 1 (2.3) | 2 (2.4) | |||
| Any treatment-related adverse event leading to death | 1 (2.5) | 0 (0.0) | 1 (1.2) | |||
| Grade 1–2 any treatment-related adverse events occurring in ≥5% of patients in either group and all grade ≥3 any treatment-related adverse events | ||||||
| Hematological toxicities | ||||||
| Decreased white blood cell count | 10 (25.0) | 3 (7.5) | 5 (11.7) | 4 (9.4) | 15 (18.1) | 7 (8.4) |
| Decreased neutrophil count | 7 (17.5) | 1 (2.5) | 7 (16.3) | 4 (9.3) | 14 (16.9) | 5 (6.0) |
| Decreased platelet count | 8 (20.0) | 2 (5.0) | 2 (4.7) | 0 (0.0) | 10 (12.0) | 2 (2.4) |
| Decreased lymphocyte count | 1 (2.5) | 0 (0.0) | 3 (7.0) | 1 (2.3) | 4 (4.8) | 1 (1.2) |
| Anemia | 10 (25.0) | 2 (5.0) | 6 (13.9) | 2 (4.6) | 16 (19.3) | 4 (4.8) |
| Myelosuppression | 2 (5.0) | 2 (5.0) | 0 (0.0) | 0 (0.0) | 2 (2.4) | 2 (2.4) |
| Febrile neutropenia | 1 (2.5) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.2) |
| Non-hematological toxicities | ||||||
| Alanine aminotransferase increased | 15 (37.5) | 0 (0.0) | 5 (11.6) | 0 (0.0) | 20 (24.1) | 0 (0.0) |
| Increased amylase | 6 (15.0) | 1 (2.5) | 11 (25.6) | 0 (0.0) | 17 (20.5) | 1 (1.2) |
| Aspartate aminotransferase increased | 11 (27.5) | 0 (0.0) | 6 (14.0) | 0 (0.0) | 17 (20.5) | 0 (0.0) |
| C-reactive protein increased | 3 (7.5) | 0 (0.0) | 3 (7.0) | 0 (0.0) | 6 (7.2) | 0 (0.0) |
| Gamma-glutamyltransferase increased | 2 (5.0) | 0 (0.0) | 4 (9.3) | 1 (2.3) | 6 (7.2) | 1 (1.2) |
| Blood bilirubin increased | 4 (10.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 5 (6.0) | 0 (0.0) |
| Weight decreased | 3 (7.5) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 5 (6.0) | 0 (0.0) |
| Blood lactate dehydrogenase increased | 1 (2.5) | 0 (0.0) | 3 (7.0) | 0 (0.0) | 4 (4.8) | 0 (0.0) |
| Blood thyroid stimulating hormone increased | 2 (5.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Blood pressure increased | 2 (5.0) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 2 (2.4) | 1 (1.2) |
| Diarrhea | 3 (7.5) | 0 (0.0) | 6 (14.0) | 0 (0.0) | 9 (10.8) | 0 (0.0) |
| Constipation | 4 (10.0) | 0 (0.0) | 4 (9.3) | 0 (0.0) | 8 (9.6) | 0 (0.0) |
| Nausea | 4 (10.0) | 0 (0.0) | 4 (9.3) | 0 (0.0) | 8 (9.6) | 0 (0.0) |
| Vomiting | 2 (5.0) | 0 (0.0) | 6 (14.0) | 0 (0.0) | 8 (9.6) | 0 (0.0) |
| Toothache | 2 (5.0) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 4 (4.8) | 0 (0.0) |
| Abdominal distension | 2 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.4) | 0 (0.0) |
| Enteritis | 1 (2.5) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.2) |
| Epistaxis | 4 (10.0) | 0 (0.0) | 10 (23.3) | 0 (0.0) | 14 (16.9) | 0 (0.0) |
| Hemoptysis | 3 (7.5) | 1 (2.5) | 4 (9.3) | 0 (0.0) | 7 (8.4) | 1 (1.2) |
| Productive cough | 2 (5.0) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 4 (4.8) | 0 (0.0) |
| Cough | 0 (0.0) | 0 (0.0) | 3 (7.0) | 1 (2.3) | 3 (3.6) | 1 (1.2) |
| Dyspnoea | 2 (5.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Rash | 4 (10.0) | 0 (0.0) | 5 (11.6) | 0 (0.0) | 9 (10.8) | 0 (0.0) |
| Pruritus | 5 (12.5) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 7 (8.4) | 0 (0.0) |
| Alopecia | 0 (0.0) | 0 (0.0) | 3 (7.0) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Fatigue | 5 (12.5) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 7 (8.4) | 0 (0.0) |
| Chest discomfort | 2 (5.0) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 4 (4.8) | 0 (0.0) |
| Malaise | 2 (5.0) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 4 (4.8) | 0 (0.0) |
| Chest pain | 2 (5.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Oedema peripheral | 3 (7.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Pain | 0 (0.0) | 0 (0.0) | 2 (4.7) | 1 (2.3) | 2 (2.4) | 1 (1.2) |
| Death | 1 (2.5) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.2) |
| Proteinuria | 9 (22.5) | 0 (0.0) | 9 (20.9) | 0 (0.0) | 18 (21.7) | 0 (0.0) |
| Albuminuria | 3 (7.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Immune-related adverse events | ||||||
| Any event | 5 (12.5) | 2 (5.0) | 9 (20.9) | 0 (0.0) | 14 (16.9) | 2 (2.4) |
| Hypothyroidism | 1 (2.5) | 0 (0.0) | 4 (9.3) | 0 (0.0) | 5 (6.0) | 0 (0.0) |
| Adrenal insufficiency | 1 (2.5) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.2) |
| Hyperthyroidism | 0 (0.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
| Pruritus | 2 (5.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Rash | 1 (2.5) | 0 (0.0) | 2 (4.7) | 0 (0.0) | 3 (3.6) | 0 (0.0) |
| Amylase increased | 1 (2.5) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.2) |
| Blood thyroid stimulating hormone increased | 1 (2.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
| Hyperglycaemia | 0 (0.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
| Immune-mediated pneumonitis | 0 (0.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
n, number.