Immune-related adverse events in ≥2% of patients (safety analysis set)
| Dose verification (n=20) | PK substudy (n=57) | Phase 2 (n=223) | Total (N=300) | |||||
| Patients with an irAE, n (%) | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 |
| Aspartate aminotransferase increased | 6 (30) | 0 | 10 (18) | 1 (2) | 35 (16) | 7 (3) | 51 (17) | 8 (3) |
| Alanine aminotransferase increased | 8 (40) | 0 | 7 (12) | 1 (2) | 35 (16) | 3 (1) | 50 (17) | 4 (1) |
| Blood bilirubin increased | 9 (45) | 0 | 4 (7) | 0 | 21 (9) | 0 | 34 (11) | 0 |
| Hypothyroidism | 3 (15) | 0 | 10 (18) | 0 | 18 (8) | 0 | 31 (10) | 0 |
| Bilirubin conjugated increased | 7 (35) | 1 (5) | 5 (9) | 0 | 16 (7) | 1 (<1) | 28 (9) | 2 (<1) |
| Gamma-glutamyl transferase increased | 0 | 0 | 1 (2) | 1 (2) | 12 (3) | 11 (5) | 13 (4) | 12 (4) |
| Rash | 1 (5) | 0 | 4 (7) | 0 | 11 (5) | 1 (<1) | 16 (5) | 1 (<1) |
| Blood creatine phosphokinase increased | 2 (10) | 0 | 2 (4) | 0 | 8 (4) | 1 (<1) | 12 (4) | 1 (<1) |
| Diarrhea | 3 (15) | 0 | 3 (5) | 0 | 6 (3) | 1 (<1) | 12 (4) | 1 (<1) |
| Hyperthyroidism | 2 (10) | 0 | 1 (2) | 0 | 8 (4) | 0 | 11 (4) | 0 |
| Pruritus | 1 (5) | 0 | 2 (4) | 0 | 6 (3) | 0 | 9 (3) | 0 |
| Blood creatine increased | 1 (5) | 0 | 0 | 0 | 6 (3) | 0 | 7 (2) | 0 |
| Hyperglycemia | 0 | 0 | 1 (2) | 0 | 4 (2) | 1 (<1) | 5 (2) | 1 (<1) |
| Pneumonia | 0 | 0 | 0 | 2 (4) | 2 (1) | 2 (<1) | 2 (<1) | 4 (1) |
| Pruritus generalized | 1 (5) | 0 | 3 (5) | 0 | 2 (1) | 0 | 6 (2) | 0 |
irAE, immune-related adverse event; PK, pharmacokinetic.