Table 2.
Incidence of the least common any grade irAEs in pivotal first-line metastatic studies
Study name | Immunotherapy and dose | Additional agents | Tumour | irAEs | Incidence (%) |
---|---|---|---|---|---|
Checkmate 067 [10] |
Ipilimumab 3 mg/kg Nivolumab 1 mg/kg |
Nil | Melanoma |
Hypersensitivity Renal Pneumonitis |
4 7 8 |
KEYNOTE 024 [11] | Pembrolizumab 200 mg | Nil | NSCLC |
T1DM Pancreatitis Nephritis |
0.6 0.6 0.6 |
Checkmate 214 [12] |
Ipilimumab 1 mg/kg Nivolumab 3 mg/kg |
Nil | RCC |
Thrombocytopenia PPE HTN |
< 1 < 1 < 1 |
KEYNOTE 048 [13] | Pembrolizumab 200 mg | Monotherapy, platinum and 5-FU based chemotherapy arms | Head and neck SqCC |
Uveitis Hypophysitis Encephalitis |
< 1 < 1 < 1 |
IMbrave150 [14] | Atezolizumab 1200 mg | Bevacizumab 15 mg/kg | HCC |
PPE Alopecia Asthenia |
0.9 1.1 6.7 |
TOPAZ-1 [15] | Durvalumab 1500 mg |
Cisplatin Gemcitabine |
Cholangiocarcinoma |
Thyroiditis Hypophysitis Pancreatitis |
0.3 0.3 0.3 |
Checkmate 649 [16] | Nivolumab 240 mg or 360 mg | FOLFOX | Gastric adenocarcinoma |
Renal Pulmonary Endocrine |
3 5 14 |
JAVELIN Bladder 100 [17] | Avelumab 10 mg/kg | Cisplatin/carboplatin-gemcitabine | Urothelial carcinoma |
Infusion reaction Anaemia Rash |
10.2 11.3 11.6 |
Checkmate 743 |
Ipilimumab 1 mg/kg Nivolumab 3 mg/kg |
Nil | Mesothelioma |
Opsoclonus myoclonus Vasculitis AST rise |
0.3 0.3 0.3 |
HCC hepatocellular carcinoma, HTN hypertension, irAE immune-related adverse event, NSCLC non-small cell lung cancer, PPE palmar-plantar erythrodysesthesia, RCC renal cell carcinoma, SqCC squamous cell carcinoma, T1DM type 1 diabetes mellitus