Adverse reactions in the EPCORETM NHL-1 trial1

The safety of EPKINLY was evaluated in 157 patients with R/R LBCL ≥2 lines of therapy1

Adverse Reactions (≥10%) All Grades (%) Grade 3 or 4* (%)
Cytokine release syndrome 51 2.5
Fatigue 29 2.5
Musculoskeletal pain 28 1.3
Injection site reactions 27 0
Pyrexia 24 0
Abdominal pain 23 1.9
Nausea 20 1.3
Diarrhea 20 0
Rash 15 0.6
Edema 14 1.9
Headache 13 0.6
Vomiting 12 0.6
Decreased appetite 12 0.6
Cardiac arrhythmias 10 0.6

*Only grade 3 adverse reactions occurred.

  • Median duration of exposure was 5 cycles (range: 1-20 cycles)
  • Serious adverse reactions occurred in 54% of patients (reactions occurring ≥2%: CRS, infections, pleural effusion, febrile neutropenia, fever, and ICANS)
  • Fatal adverse reactions occurred in 3.8% of patients (1.3% COVID-19, 0.6% hepatotoxicity, 0.6% ICANS, 0.6% myocardial infarction, 0.6% pulmonary embolism)
  • Discontinuation due to an adverse reaction occurred in 3.8% of patients (reactions included COVID-19, CRS, ICANS, pleural effusion, and fatigue)
  • Dosage interruptions due to an adverse reaction occurred in 34% of patients (reactions occurring ≥3%: CRS, neutropenia, sepsis, and thrombocytopenia)
  • The most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets
  • Clinically relevant adverse reactions in <10% of patients included ICANS, sepsis, pleural effusion, COVID-19, pneumonia, tumor flare, febrile neutropenia, upper respiratory tract infections, and tumor lysis syndrome

Term includes other related terms. See Prescribing Information.

CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; LBCL=large B-cell lymphoma; NHL=non-Hodgkin lymphoma; R/R=relapsed/refractory.

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See CRS & ICANS events that occurred in the clinical trial