Table 2.
Common treatment-related adverse events observed with ipilimumab monotherapy at 10 mg/kg in a phase 2 study 26
| Ipilimumab –XRT n = 16 (%) | Ipilimumab +XRT n = 34 (%) | Ipilimumab overall (±XRT) n = 50 (%) | |
|---|---|---|---|
| Any treatment-related AE | |||
| Any Grade | 16 (100) | 29 (85) | 45 (90) |
| Grade 3 | 7 (44) | 13 (38) | 20 (40) |
| Grade 4 | 3 (19) | 0 | 3 (6) |
| Any immune-related AE (irAE) | |||
| Any Grade | 16 (100) | 29 (85) | 45 (90) |
| Grade 3 | 7 (44) | 13 (38) | 20 (40) |
| Grade 4 | 3 (19) | 0 | 3 (6) |
| Common1 irAEs: any grade; Grade 3 | |||
| Colitis | 7 (44); 6 (38) | 4 (12); 2 (6) | 11 (22); 8 (16) |
| Diarrhea | 13 (81); 2(13) | 14 (41); 2 (6) | 27 (54); 4 (8) |
| Rash | 9 (56); 0 | 7 (21); 0 | 16 (32); 0 |
| Pruritus | 6 (38); 1 (6) | 4 (12); 0 | 10 (20); 1 (2) |
| Common7 laboratory abnormalities2: any grade; Grade 3; Grade 4 | |||
| Evaluable patients | 15 | 34 | 49 |
| Hemoglobin | 12 (80); 1 (7); 0 | 28 (82); 6 (18); 0 | 40 (82); 7 (14); 0 |
| Lymphocytes | 12 (80); 2 (13); 0 | 31 (91); 3 (9); 0 | 43 (88); 5 (10); 0 |
| ALT | 7 (47); 1 (7); 1 (7) | 10 (29); 1 (3); 0 | 17 (35); 2 (4); 1 (2) |
| AST | 6 (40); 1 (7); 1 (7) | 8 (24); 0; 0 | 14 (29); 1 (2); 1 (2) |
| AP | 7 (47); 1 (7); 0 | 21 (62); 4 (12); 1 (3) | 28 (57); 5 (10); 1 (2) |
| Amylase | 4 (27); 0; 0 | 4 (12); 1 (3); 0 | 8 (16); 1 (2); 0 |
XRT, radiotherapy; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AP, alkaline phosphatase; irAE, immune-related adverse event. Data from Slovin et al. 26.
1
Defined as AE or laboratory abnormality of any grade in ≥15% of patients in the 10 mg/kg ± XRT group.
2
Calculated from laboratory values.