Table 2.
Summary of AEs in Parts 1 and 2
| AE, n (%) | Part 1 GSK3174998 (n=45) | |
| All grades | Grade ≥3* | |
| Any AE, n (%) | 45 (100) | 18 (40) |
| Any TRAE, n (%) | 23 (51) | 3 (7) |
| TRAE in ≥5% patients | ||
| Diarrhea | 5 (11) | 0 |
| Fatigue | 5 (11) | 0 |
| Nausea | 4 (9) | 0 |
| Decreased appetite | 3 (7) | 0 |
| Myalgia | 3 (7) | 0 |
| Treatment-related SAE | 2 (4) | 1 (2) |
| Infusion-related reaction | 2 (4) | 1 (2) |
| TRAE leading to dose delay/interruption | 3 (7) | 2 (4) |
| TRAE leading to discontinuation | 0 | 0 |
| DLT | 0 | 0 |
| AE, n (%) | Part 2 GSK3174998+pembrolizumab (n=96) | |
| All grades | Grade ≥3* | |
| Any AE, n (%) | 95 (99) | 33 (34) |
| Any TRAE, n (%) | 61 (64) | 8 (8) |
| TRAE in ≥5% patients | ||
| Fatigue | 23 (24) | 3 (3) |
| Nausea | 10 (10) | 0 |
| Pruritus | 7 (7) | 0 |
| Arthralgia | 6 (6) | 0 |
| Fever | 6 (6) | 0 |
| Diarrhea | 5 (5) | 1 (1) |
| Rash | 5 (5) | 0 |
| Rash (maculopapular) | 5 (5) | 0 |
| Treatment-related SAE | 4 (4)† | 2 (2) |
| Fatigue | 2 (2) | 2 (2) |
| Increased blood creatine kinase | 1 (1) | 0 |
| Myocarditis | 1 (1) | 0 |
| Organizing pneumonia | 1 (1) | 0 |
| TRAE leading to dose delay/interruption | 10 (10) | 2 (2) |
| TRAE leading to discontinuation | 3 (3) | 2 (2) |
| DLT | 2 (2) | 2 (2) |
| G3 pleural effusion | 1 (1) | 1 (1) |
| G1 myocarditis with G3 increased troponin | 1 (1) | 1 (1) |
*There were no G4 or G5 TRAEs.
†Increased blood creatine kinase and myocarditis occurred in the same patient.
AE, adverse event; DLT, dose-limiting toxicity; G, grade; SAE, serious adverse event; TRAE, treatment-related adverse event.