Table 1. Summary of adverse events in NEON-1 and NEON-2.
AE, n patients (%) | NEON-1n=58 | NEON-2n=29 |
Any grade TEAE | 58 (100) | 26 (90) |
Any grade TRAE | 39 (67) | 18 (62) |
Any AE of Interest | 26 (45) | 11 (38) |
irAE | 21 (36) | 9 (31) |
IRR | 9 (16) | 1 (3) |
Cytokine release syndrome | 0 | 0 |
Anaphylaxis | 0 | 0 |
Any grade ≥3 TEAE | 32 (55) | 18 (62) |
Any grade ≥3 TRAE | 7 (12) | 7 (24) |
Any grade ≥3 irAE | 3 (5) | 3 (10) |
Acute kidney injury | 1 (2) | 0 |
Cardiogenic shock | 0 | 1 (3) |
Gastritis | 1 (2) | 0 |
Immune-mediated myocarditis | 0 | 1 (3) |
Testicular pain | 1 (2) | 0 |
Tubulointerstitial nephritis | 0 | 1 (3) |
Urticaria | 1 (2) | 0 |
Adverse events were graded according to Common Terminology Criteria for Adverse Events V.5.0. For administration-related reactions, IRR was generally used unless more specific terms (ie, cytokine release syndrome or anaphylaxis) were definitively determined.
AEadverse eventirAEimmune-related adverse eventIRRinfusion-related reactionTEAEtreatment-emergent adverse eventTRAEtreatment-related adverse event