Table 3.
Safety data from key studies
| Checkmate 214[43] | IMmotion 151[58] | KEYNOTE 426[59,60] | JAVELIN renal 101[61,62] | Checkmate 9ER[63] | CLEAR[29] | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||||||
| Nivo/Ipi ( N = 547) | Sun (N = 535) | Atezo/Bev ( N = 454) | Sun (N = 461) | Axi/Pembro ( N = 432) | Sun (N = 429) | Axi/Avel ( N = 442) | Sun (N = 444) | Cabo/Nivo ( N = 323) | Sun (N = 328) | Lenv/Pembro ( N = 454) | Lenv/Evero ( N = 461) | Sun (N = 461) | |
| Dose reductions, % | - | 53 | - | 37 | 20 | 28 | 42 | 43 | 56 | 52 | 68 | 73 | 50 |
| AE leading to discontinuation of entire treatment regimen, % | 22 | 13 | 5 | 8 | 7 | 12 | 8 | 13 | 5.6 | 17 | 13 | 19 | 14 |
| Treatment-related deaths, n | 8 | 4 | 5 | 1 | 4 | 7 | 3 | 1 | 1 | 2 | 4 | 3 | 1 |
| Treatment-emergent AE, grades 3–4%a | 47 | 64 | 40 | 54 | 67 | 62 | 71 | 71 | 61 | 51 | 82 | 83 | 72 |
| Corticosteroids for IRAE, %a | 29 | - | 16 | - | NR | - | 11 | - | 16 | - | NR | - | - |
| Grade 3/4 AEs, % Hypertension | < 1 | 16 | 14 | 17 | 21 | 18 | 26 | 17 | 13 | 13 | 28 | 23 | 19 |
| Fatigue | 4 | 9 | 1 | 5 | 2 | 5 | 4 | 4 | 3 | 5 | 4 | 8 | 4 |
| Diarrhea | 4 | 5 | 2 | 4 | 7 | 5 | 7 | 3 | 7 | 4 | 10 | 12 | 5 |
| PPE | 0 | 9 | 0 | 9 | 5 | 4 | 6 | 4 | 8 | 8 | 4 | 3 | 4 |
| Weight Loss | - | - | - | - | - | - | 3 | 1 | 1 | 0 | 8 | 7 | < 1 |
| Decreased appetite | 1 | 1 | < 1 | 2 | 2 | < 1 | 2 | 1 | 2 | 1 | 4 | 6 | 2 |
| Proteinuria | - | - | 3 | < 1 | 3 | 3 | - | - | 3 | 2 | 8 | 8 | 3 |
| Grade 3/4 laboratory abnormalities, % Hypothyrodiism | < 1 | < 1 | < 1 | < 1 | < 1 | 0 | < 1 | < 1 | < 1 | < 1 | 1 | 1 | 0 |
| Increased lipase | 10 | 7 | - | - | - | - | - | - | 6 | 5 | 13 | 4 | 9 |
| Neutropenia | - | - | < 1 | 4 | < 1 | 7 | < 1 | 8 | < 1 | 4 | 1 | 1 | 6 |
| Anemia | 0 | 4 | < 1 | 4 | < 1 | 3 | 2 | 8 | 2 | 4 | 2 | 4 | 5 |
| Thrombocytopenia | 0 | 5 | 1 | 5 | 0 | 5 | < 1 | 6 | < 1 | 5 | 1 | 4 | 6 |
| Increased ALT | 5 | 2 | - | - | 12 | 3 | 6 | 3 | 5 | 2 | 4 | 3 | 2 |
| Increased AST | 4 | 1 | - | - | 7 | 2 | 4 | 2 | 3 | 1 | 3 | 2 | 1 |
a
Listed are adverse events with a possible immune-mediated cause and infusion reactions that occurred during study treatment or within the 90 days thereafter, regardless of attribution to study treatment or immune relatedness by the investigator. AE: Adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; Atezo: atezolizumab; Avel: avelumab; Axi: axitinib; Bev: bevacizumab; Cabo: cabozantinib; Evero: everolimus; Ipi: ipilimumab; Lenv: lenvatinib; Nivo: nivolumab; NR: not reported; PPE: palmar-plantar erythrodysthesia; Sun: sunitinib; -: not reported.