Table 3.
Feladilimab mg/tremelimumab mg | ||||||
---|---|---|---|---|---|---|
Preferred term, n (%) | 8/75 (N = 1) | 24/75 (N = 1) | 8/225 (N = 5) | 80/75 (N = 3) | 24/225 (N = 16) | Total (N = 26) |
AEs leading to permanent discontinuation | 0 | 0 | 1 (20) | 0 | 3 (19) | 4 (15) |
Colitis | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
Diarrhea | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
Fatigue | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
Acute kidney injury | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
Dyspnea | 0 | 0 | 1 (20) | 0 | 0 | 1 (4) |
AESIs | 0 | 0 | 2 (40) | 0 | 7 (44) | 9 (25) |
Colitis | 0 | 0 | 1 (20) | 0 | 1 (6) | 2 (8) |
Endocrinopathies | 0 | 0 | 0 | 0 | 2 (13) | 2 (8) |
Hepatitis | 0 | 0 | 1 (20) | 0 | 0 | 1 (4) |
Nephritis and renal function | 0 | 0 | 0 | 0 | 2 (13) | 2 (8) |
Other immune-mediated AEs | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
Skin adverse reactions | 0 | 0 | 2 (40) | 0 | 3 (19) | 5 (19) |
Individual patients could experience ≥ 1 listed AE
AE adverse event, AESI adverse event of special interest