Table 2.
Treatment‐related adverse event summary in patients treated with urelumab or urelumab plus rituximab
| Urelumab | Urelumab Plus Rituximab | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 mg Q3W (n = 25) | 8 mg Q6W (n = 25) | 0.3 mg/kg (n = 10) | All patients (N = 60) | 0.1 mg/kg (n = 17) | 8 mg Q3W (n = 23) | 0.3 mg/kg (n = 6) | All patients (N = 46) | |||||||||
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| All TRAEs, n (%) | 12 (48) | 6 (24) | 11 (44) | 2 (8) | 8 (80) | 1 (10) | 31 (52) | 9 (15) | 13 (76) | 7 (41) | 16 (70) | 5 (22) | 4 (67)a | 1 (17) | 33 (72)a | 13 (28) |
| TRAEs (> 2 patients in either study), n (%) | ||||||||||||||||
| Hematologic AEs | ||||||||||||||||
| Neutropenia | 5 (20) | 5 (20) | 2 (8) | 2 (8) | 0 | 0 | 7 (12) | 7 (12) | 5 (29) | 5 (29) | 0 | 0 | 1 (17) | 0 | 6 (13) | 5 (11) |
| Thrombocytopenia | 2 (8) | 1 (4) | 1 (4) | 0 | 0 | 0 | 3 (5) | 1 (2) | 2 (12) | 0 | 1 (4) | 1 (4) | 2 (33) | 1 (17) | 5 (11) | 2 (4) |
| Anemia | 1 (4) | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 1 (6) | 0 | 1 (4) | 1 (4) | 1 (17) | 0 | 3 (7) | 1 (2) |
| Leukopenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (18) | 2 (12) | 0 | 0 | 1 (17) | 1 (17) | 4 (9) | 3 (7) |
| Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 1 (6) | 1 (4) | 0 | 1 (17) | 1 (17) | 3 (7) | 2 (4) |
| Nonhematologic AEs | ||||||||||||||||
| Fatigue | 1 (4) | 0 | 4 (16) | 0 | 4 (40) | 0 | 9 (15) | 0 | 3 (18) | 0 | 6 (26) | 1 (4) | 0 | 0 | 9 (20) | 1 (2) |
| AST increased | 1 (4) | 1 (4) | 1 (4) | 0 | 1 (10) | 0 | 3 (5) | 1 (2) | 2 (12) | 0 | 4 (17) | 0 | 1 (17) | 0 | 7 (15) | 0 |
| Increased blood alkaline phosphatase | 1 (4) | 0 | 0 | 0 | 2 (20) | 0 | 3 (5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 2 (8) | 0 | 0 | 0 | 0 | 0 | 2 (3) | 0 | 1 (6) | 0 | 3 (13) | 0 | 1 (17) | 0 | 5 (11) | 0 |
| Diarrhea | 2 (8) | 0 | 0 | 0 | 0 | 0 | 2 (3) | 0 | 1 (6) | 0 | 3 (13) | 0 | 0 | 0 | 4 (9) | 0 |
| ALT increased | 1 (4) | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 1 (6) | 0 | 4 (17) | 1 (4) | 1 (17) | 0 | 6 (13) | 1 (2) |
| Infusion‐related reaction | 0 | 0 | 1 (4) | 0 | 0 | 0 | 1 (2) | 0 | 1 (6) | 0 | 2 (9) | 0 | 1 (17) | 0 | 4 (9) | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 1 (6) | 2 (9) | 0 | 0 | 0 | 3 (7) | 1 (2) |
| Constipation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 2 (9) | 0 | 0 | 0 | 3 (7) | 0 |
| Lipase increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 | 1 (4) | 0 | 1 (17) | 0 | 3 (7) | 0 |
| Serious TRAEs, n (%) | 2 (8) | 2 (8) | 1 (4) | 0 | 1 (10) | 1 (10) | 4 (7) | 3 (5) | 0 | 0 | 1 (4) | 1 (4) | 1 (17)a | 0 | 2 (4)a | 1 (2) |
| TRAEs leading to discontinuation, n (%) | 1 (4)b | 1 (4)b | 0 | 0 | 1 (10)c | 1 (10)c | 2 (3)b , c | 2 (3)b , c | 0 | 0 | 0 | 0 | 1 (17)a | 0 | 1 (2)a | 0 |
Abbreviations: AE, adverse event; AST, aspartate aminotransferase; DLBCL, diffuse large B‐cell lymphoma; FL, follicular lymphoma; Q3W, every 3 weeks; Q6W, every 6 weeks; TRAE, treatment‐related adverse event.
a
Death due to sepsis syndrome in a patient with FL who had received treatment with nivolumab 32 days prior to study entry.
b
Grade 3 increased AST in patient with DLBCL.
c
Grade 4 acute hepatitis in patient with FL.