Table 4.
Event, n (%) | Nivolumab (n=18) |
Nivolumab plus ipilimumab (n=21) | Nivolumab plus ipilimumab plus cobimetinib (n=30) | |||
Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
Rash | 0 | 0 | 2 (10) | 0 | 5 (17) | 0 |
Diarrhea | 1 (6) | 0 | 4 (19) | 1 (5) | 1 (3) | 0 |
Maculopapular rash | 2 (11) | 1 (6) | 0 | 0 | 3 (10) | 1 (3) |
AST increased | 0 | 0 | 2 (10) | 2 (10) | 1 (3) | 0 |
Colitis | 1 (6) | 1 (6) | 1 (5) | 1 (5) | 0 | 0 |
ALT increased | 0 | 0 | 1 (5) | 1 (5) | 1 (3) | 0 |
Pneumonitis | 0 | 0 | 0 | 0 | 2 (7) | 0 |
Blood bilirubin increased | 0 | 0 | 1 (5) | 1 (5) | 0 | 0 |
Hyperbilirubinemia | 0 | 0 | 1 (5) | 1 (5) | 0 | 0 |
Autoimmune thyroiditis | 0 | 0 | 1 (5) | 1 (5) | 0 | 0 |
Vesicular rash | 0 | 0 | 0 | 0 | 1 (3) | 1 (3) |
Adrenal insufficiency | 0 | 0 | 0 | 0 | 1 (3) | 1 (3) |
Hyperthyroidism | 0 | 0 | 1 (5) | 0 | 0 | 0 |
*Endocrine AEs (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis) were considered immune-mediated AEs regardless of immune-modulating medication use, as endocrine drug reactions are often managed without immune-modulating medication.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.