Safety
death, pembrolizumab, diarrhea, TEAEs, dislocation, SAEs, TEAEs of
ADVERSE EVENT, PANCREATITIS, GASTROINTESTINAL DISORDERS, SUPERIOR VENA CAVA SYNDROME
All 19 patients experienced treatment‐emergent AEs (TEAEs), of which most were of CTCAE Grade 1 or 2. A total of 19 (100%) and 18 (94.7%) patients reported TEAEs related to EVER4010001 or pembrolizumab, respectively. All 19 patients experienced TEAEs of gastrointestinal disorders; the most common was diarrhea (18/19 patients, 94.7%) (Table Most common EVER4010001 and pembrolizumab‐related TEAEs of any grade (observed in ≥10% of patients) or grade ≥3 (observed in ≥5% of patients)Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; TEAE, treatment‐emergent adverse event.Data were coded using MedDRA V24.0.A total of 9 (47.4%) patients reported Grade ≥3 TEAEs, of which 3 (15.8%) were related to both EVER4010001 and pembrolizumab. The remaining six patients reported Grade ≥3 TEAEs unrelated to EVER4010001 or pembrolizumab which were not confined to a small group of PTs. The most common Grade ≥3 TEAEs by PT were increased ALT (2 [10.5%]), increased AST (2 [10.5%]), and increased blood bilirubin (2 [10.5%]) (Table A total of 4 (21.1%) patients experienced TEAEs which led to discontinuation of EVER4010001 and pembrolizumab due to increased AST (2 [10.5%]), increased blood bilirubin (1 [5.3%]), and superior vena cava syndrome (19 [5.3%]) (Table Only 2 (10.5%) patients (40 and 60 mg) experienced serious AEs (SAEs); none were related to EVER4010001 or pembrolizumab. SAEs by PT included pancreatitis, device dislocation, and a death of unknown cause (Table 