Summary of grade 3 or higher TEAEs with modakafusp alfa
| System organ class and TEAE . | Modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Any grade ≥3 TEAEs, n (%) | 64 (90.1) | 72 (96.0) | 136 (93.2) |
| Blood and lymphatic system, n (%) | 61 (85.9) | 69 (92.0) | 130 (89.0) |
| Neutropenia | 40 (56.3) | 51 (68.0) | 91 (62.3) |
| Thrombocytopenia | 39 (54.9) | 46 (61.3) | 85 (58.2) |
| Leukopenia | 12 (16.9) | 24 (32.0) | 36 (24.7) |
| Anemia | 14 (19.7) | 17 (22.7) | 31 (21.2) |
| Lymphopenia | 0 | 4 (5.3) | 4 (2.7) |
| Infections and infestations, n (%) | 15 (21.1) | 11 (14.7) | 26 (17.8) |
| Pneumonia | 6 (8.5) | 6 (8.0) | 12 (8.2) |
| Sepsis | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Urinary tract infection | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Investigations, n (%) | 7 (9.9) | 9 (12.0) | 16 (11.0) |
| Lymphocyte count decreased | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| ALT increased | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| AST increased | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Respiratory, n (%) | 4 (5.6) | 11 (14.7) | 15 (10.3) |
| Dyspnea | 1 (1.4) | 3 (4.0) | 4 (2.7) |
| Hypoxia | 1 (1.4) | 2 (2.7) | 3 (2.1) |
| Metabolism and nutrition, n (%) | 4 (5.6) | 9 (12.0) | 13 (8.9) |
| Hypercalcemia | 3 (4.2) | 3 (4.0) | 6 (4.1) |
| Hypokalemia | 1 (1.4) | 3 (4.0) | 4 (2.7) |
| General disorders, n (%) | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| Asthenia | 3 (4.2) | 3 (4.0) | 6 (4.1) |
| Injury, poisoning, and procedure complications, n (%) | 3 (4.2) | 5 (6.7) | 8 (5.5) |
| IRR | 2 (2.8) | 2 (2.7) | 4 (2.7) |
| Renal and urinary disorders, n (%) | 6 (8.5) | 2 (2.7) | 8 (5.5) |
| Acute kidney injury | 5 (7.0) | 2 (2.7) | 7 (4.8) |
| System organ class and TEAE . | Modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Any grade ≥3 TEAEs, n (%) | 64 (90.1) | 72 (96.0) | 136 (93.2) |
| Blood and lymphatic system, n (%) | 61 (85.9) | 69 (92.0) | 130 (89.0) |
| Neutropenia | 40 (56.3) | 51 (68.0) | 91 (62.3) |
| Thrombocytopenia | 39 (54.9) | 46 (61.3) | 85 (58.2) |
| Leukopenia | 12 (16.9) | 24 (32.0) | 36 (24.7) |
| Anemia | 14 (19.7) | 17 (22.7) | 31 (21.2) |
| Lymphopenia | 0 | 4 (5.3) | 4 (2.7) |
| Infections and infestations, n (%) | 15 (21.1) | 11 (14.7) | 26 (17.8) |
| Pneumonia | 6 (8.5) | 6 (8.0) | 12 (8.2) |
| Sepsis | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Urinary tract infection | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Investigations, n (%) | 7 (9.9) | 9 (12.0) | 16 (11.0) |
| Lymphocyte count decreased | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| ALT increased | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| AST increased | 2 (2.8) | 1 (1.3) | 3 (2.1) |
| Respiratory, n (%) | 4 (5.6) | 11 (14.7) | 15 (10.3) |
| Dyspnea | 1 (1.4) | 3 (4.0) | 4 (2.7) |
| Hypoxia | 1 (1.4) | 2 (2.7) | 3 (2.1) |
| Metabolism and nutrition, n (%) | 4 (5.6) | 9 (12.0) | 13 (8.9) |
| Hypercalcemia | 3 (4.2) | 3 (4.0) | 6 (4.1) |
| Hypokalemia | 1 (1.4) | 3 (4.0) | 4 (2.7) |
| General disorders, n (%) | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| Asthenia | 3 (4.2) | 3 (4.0) | 6 (4.1) |
| Injury, poisoning, and procedure complications, n (%) | 3 (4.2) | 5 (6.7) | 8 (5.5) |
| IRR | 2 (2.8) | 2 (2.7) | 4 (2.7) |
| Renal and urinary disorders, n (%) | 6 (8.5) | 2 (2.7) | 8 (5.5) |
| Acute kidney injury | 5 (7.0) | 2 (2.7) | 7 (4.8) |