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.
