Table 2:
Immune-related adverse events | Anti–CTLA-4 (ipilimumab) | Anti–PD-1 (nivolumab) | Anti–CTLA4 + Anti–PD1 (ipilimumab + nivolumab) | |||
---|---|---|---|---|---|---|
|
|
|
||||
Any grade, % | Grade ≥ 3,† % | Any grade, % | Grade ≥ 3,† % | Any grade, % | Grade ≥ 3,† % | |
All immune-related adverse events | 86 | 27 | 82 | 16 | 96 | 55 |
| ||||||
Rash | 33 | 2 | 26 | 1 | 40 | 5 |
| ||||||
Colitis | 12 | 9 | 1 | 1 | 12 | 8 |
| ||||||
Diarrhea | 33 | 6 | 20 | 2 | 44 | 10 |
| ||||||
Hepatitis | 4 | 2 | 4 | 1 | 18 | 8 |
| ||||||
Hypothyroidism | 4 | 0 | 9 | 0 | 15 | 1 |
| ||||||
Discontinuation owing to immune-related adverse events | 15 | 13 | 8 | 5 | 36 | 30 |
Note: CTLA-4 = cytotoxic T-lymphocyte–associated protein 4, irAE = immune-related adverse events, PD-1 = programmed cell death 1.
Results are based on a large phase 3 clinical trial comparing the efficacy and safety of single-agent PD-1, CTLA-4 or the combination in metastatic melanoma.6 Similar immune-related adverse events rates are reproducible in other cancer types.
Grade 3 = severe or medically important but not immediately life-threatening; hospital admission indicated; disabling; limiting self-care, per Common Terminology Criteria for Adverse Events.12