Adverse reactions were manageable with subcutaneous EPKINLY1
Majority of adverse reactions were mild to moderate (grade 1 or 2)1
Most common treatment-related adverse reactions (≥10%, N=157)
| ADVERSE REACTIONS* | 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 |
- 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)
- Most adverse reactions occurred early in treatment (C1-3), and incidence declined after 12 weeks2
*Adverse reactions were graded based on CTCAE Version 5.0.
†CRS was graded using ASTCT consensus criteria (Lee et al., 2019).
‡Only grade 3 adverse reactions occurred.
§Term includes other related terms. See full Prescribing Information.
- 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)
- Most adverse reactions occurred early in treatment (C1-3), and incidence declined after 12 weeks2
Low discontinuation rate (3.8%) due to any adverse reaction
- Adverse reactions that led to discontinuation 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)
ASTCT=American Society for Transplantation and Cellular Therapy; C1-3=cycles 1-3; CRS=cytokine release syndrome; CTCAE=Common Terminology Criteria for Adverse Events; ICANS=immune effector cell-associated neurotoxicity syndrome.
