Immune Related Adverse Events (irAEs) and Serious irAEs Reported

IrAEs related to Interleukin-2

1. 70% low level requiring no to minimal intervention

a. Vitiligo in mM patients

b. Thyroid dysfunction: 3 times more common in mRCC than mM

2. <5% irAEs reported requiring intervention (holding IL-2)

a. joint pain

b. Neuropathy

c. Hepatitis by enzyme elevation

15 Serious irAEs reported in overall Data Base among 152 irAEsa

6 in patients with mRCC – all during IL-2

9 in mM patients – 4 during IL-2; 5 after IL-2

9 patients - Myocarditis – all during IL-2

7 patients, only enzyme release; no clinical, electrocardiogram or echocardiogram findings

2 patients – elevated enzymes; 1- abnormal electrocardiogram and symptoms; 1 – elevated enzymes and asymptomatic ventricular arrhythmia.

1 patient each - Myasthenia Gravis, Guillain Barre - both related to IL-2

4 serious irAEs reported related to CPIa: 1 each: colitis, encephalopathy, neuropathy, uveitis

^airAEs related to CPI were not required to be reported