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Characteristics of Cytokine Release Syndrome

CRS was reversible, manageable, most severe in cycle 1 and associated with fever, hypotension, transient transaminitis,

nausea/vomiting and/or diarrhea (Lee 2014 grading)

– No grade 4/5 CRS events or treatment discontinuations

– 26 (60.5%) patients had grade 2 CRS as worst grade (hypotension: 15 [34.9%]; transaminitis: 13[30.2%])*

– 11 (25.6%) patients had grade 3 CRS as worst grade (hypotension: 6 [14.0%]; transaminitis: 10 [23.3%])*

– Transaminitis events were short-term AST/ALT elevations not associated with long-term hepatic dysfunction
◆
– 4 (9.3%) patients experienced reversible atrial fibrillation in setting ofCRS/tachycardia
CRS Grading (Lee 2014)

Grade 1 Grade 2 Grade 3 Grade 4 †
Fever, nausea, fatigue, etc,
requiring symptomatic Grade 1 CRS symptoms and Grade 1 CRS symptoms and Grade 1 CRS symptoms and
treatment only • O requirement  40% • O requirement  40% • Requirement for
ventilator
2
2
• Intravenous fluids or low- • High-dose or multiple • Grade 4 organ toxicity
dose vasopressor for vasopressors for (excluding transaminitis)
hypotension hypotension
• Grade 3 transaminitis • Grade 4 transaminitis

AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CRS = cytokine release syndrome
* Data from investigators, database-reported AEs, and laboratories (20 July2020)
† No grade 4 CRS events were observed at the time of data cutoff (20 July 2020) 8