Table 2

Immune-mediated adverse events and safety summary

IMAEs*† by categoryAll treated patients (n=106)
Any grade,
n (%)‡
Grade 3/4,
n (%)
Rash27 (25.5)7 (6.6)§
Hypothyroidism and thyroiditis21 (19.8)0
Diarrhoea/colitis15 (14.2)8 (7.5)¶
Adrenal insufficiency9 (8.5)3 (2.8)
Hyperthyroidism8 (7.5)0
Hepatitis7 (6.6)3 (2.8)**
Diabetes mellitus6 (5.7)4 (3.8)
Hypersensitivity6 (5.7)0
Pneumonitis3 (2.8)1 (0.9)
Hypophysitis3 (2.8)0
Nephritis and renal dysfunction2 (1.9)0
Treatment-related AEs*
Total94 (88.7)46 (43.4)
Treatment-related AEs (any grade) in ≥10% of all treated patients
 Fatigue49 (46.2)4 (3.8)
 Diarrhoea31 (29.2)4 (3.8)
 Nausea24 (22.6)3 (2.8)
 Pruritus23 (21.7)1 (0.9)
 Lipase increased21 (19.8)15 (14.2)
 Hypothyroidism18 (17.0)0 (0)
 Decreased appetite17 (16.0)1 (0.9)
 Amylase increased13 (12.3)5 (4.7)
 Blood creatinine increased12 (11.3)2 (1.9)
 Rash maculopapular11 (10.4)3 (2.8)
 AST increased11 (10.4)2 (1.9)
AEs leading to discontinuation*
Total30 (28.3)21 (19.8)
AEs leading to discontinuation in >1% of patients
 Colitis4 (3.8)4 (3.8)
 Malignant neoplasm progression4 (3.8)4 (3.8)
 Pneumonitis4 (3.8)2 (1.9)
 Diarrhoea4 (3.8)1 (0.9)
 Blood bilirubin increased2 (1.9)2 (1.9)
 Nausea2 (1.9)1 (0.9)
 AST increased2 (1.9)1 (0.9)
 ALT increased2 (1.9)1 (0.9)
 Pancreatitis2 (1.9)0
  • *Reported between first dose and 100 days after last dose of study drug.

  • †Adrenal insufficiency, hypothyroidism and thyroiditis, diabetes mellitus, hyperthyroidism, and hypophysitis were considered endocrine IMAEs.

  • ‡No grade 5 IMAEs were reported.

  • §Included maculopapular rash in four patients (3.8%), pruritic rash in two patients (1.9%) and erythematous rash in one patient (0.9%).

  • ¶Included diarrhoea in two patients (1.9%) and colitis in six patients (5.7%).

  • **Included blood bilirubin increased and autoimmune hepatitis (both in a single patient; 0.9%), AST increased in one patient (0.9%) and drug-induced liver injury in one patient (0.9%).

  • AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; IMAE, immune-mediated adverse event.