Table 1 Safety profile of nivolumab by dose level and tumor type
From: Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy
Dose (mg/kg Q2W) | ||||||
Patients with treatment-related AEs, % (n) | 0.1 | 0.3 | 1 | 3 | 10 | Total |
(N = 17) | (N = 18) | (N = 86) | (N = 54) | (N = 131) | (N = 306) | |
Any grade | 77 (13) | 78 (14) | 81 (70) | 74 (40) | 71 (93) | 75 (230) |
Grade 3/4 | 29 (5) | 17 (3) | 14 (12) | 20 (11) | 16 (21) | 17 (52) |
Serious grade 3/4 | 6 (1) | 0 | 5 (4) | 9 (5) | 11 (14) | 8 (24) |
Leading to DC | 18 (3) | 0 | 11 (9) | 7 (4) | 12 (16) | 11 (32) |
Deaths | – | – | 2 (2) | 4 (2) | 1 (1) | 2 (5) |
Tumor type | ||||||
Patients with treatment-related AEs, % (n) | NSCLC | MEL | RCC | CRC | mCRPC | Total |
(N = 129) | (N = 107) | (N = 34) | (N = 19) | (N = 17) | (N = 306) | |
Dose levels (mg/kg) | 1–10 | 0.1–10 | 1, 10 | 10 | 10 | |
Any grade | 71 (91) | 84 (90) | 85 (29) | 58 (11) | 53 (9) | 75 (230) |
Grade 3/4 | 14 (18) | 22 (24) | 18 (6) | 16 (3) | 6 (1) | 17 (52) |
Serious grade 3/4 | 6 (8) | 9 (10) | 9 (3) | 11 (2) | 6 (1) | 8 (24) |
Leading to DC | 12 (16) | 9 (10) | 9 (3) | 16 (3) | 0 | 11 (32) |
Deaths | 3 (4) | – | – | 5 (1) | – | 2 (5) |