Adverse reactions in the EPCORE® NHL-1 trial in patients with 3L+ FL1
Majority of ARs were mild to moderate (grade 1 or 2)
Most common treatment-related ARs (≥10%)
| Adverse Reaction* | All grades (%) | Grade 3 or 4 (%) |
|---|---|---|
| (n=86)† | ||
| Cytokine release syndromeठ| 49 | 0 |
| (n=127) | ||
| Injection site reactions|| | 58 | 0 |
| COVID-19¶ | 40 | 19 |
| Fatigue|| | 37 | 5** |
| Upper respiratory tract infection¶ | 29 | 2** |
| Musculoskeletal pain|| | 28 | 0.8** |
| Rash|| | 28 | 0 |
| Pyrexia|| | 26 | 2** |
| Diarrhea | 26 | 1.6 |
| Headache | 20 | 0 |
| Cough|| | 20 | 0 |
| Pneumonia¶ | 17 | 13** |
| Abdominal pain | 17 | 0.8** |
| Dyspnea|| | 17 | 0 |
| Edema|| | 17 | 0 |
| Nausea | 17 | 0 |
| Constipation | 16 | 0 |
| Arthralgia | 14 | 0.8** |
| Urinary tract infection|| | 13 | 5** |
| Peripheral neuropathy and paresthesia¶ | 13 | 1.6** |
| Neurological changes¶ | 13 | 0 |
| Insomnia | 13 | 0 |
| Herpes virus infection | 12 | 1.6** |
| Mucositis¶ | 12 | 0 |
| Dizziness | 11 | 0 |
| Renal insufficiency¶ | 10 | 1.6** |
*Adverse reactions were graded based on CTCAE Version 5.0.
†The frequency of CRS is based on 86 patients with FL who received the recommended 3-step up dosage schedule in EPCORE NHL-1 (see Dosage and Administration [2.2]).
‡CRS was graded using ASTCT consensus criteria (Lee et al, 2019).
§The frequency of CRS based on the 127 patients with FL who received the 2-step up dosage schedule in EPCORE NHL-1 was the following: any grade CRS: 66%; grade 1 CRS: 50%; grade 2 CRS: 26%; grade 3 CRS: 1.6%.
IIIncludes related grouped terms.
¶Term includes other related terms. See full Prescribing Information.
**Only grade 3 adverse reactions occurred.
In 86 patients who received EPKINLY following the recommended 3-step up dosage schedule:
- The median duration of exposure was 5 cycles (range: 1-12 cycles)
- CRS occurred in 49% of patients (45% grade 1, 9% grade 2)
- Serious adverse reactions due to CRS occurred in 28% of patients
- Dose interruptions due to CRS occurred in 19% of patients
In 127 patients who received EPKINLY following a 2-step up dosage schedule:
- The median duration of exposure was 8 cycles (range: 1-33 cycles)
- Serious adverse reactions occurred in 66% of patients (reactions occurring ≥5%: CRS, COVID-19, pneumonia, and second primary malignancies)
- Fatal adverse reactions occurred in 9% of patients, including COVID-19 (5%), pneumonitis (1.6%), cardiac failure (0.8%), pneumonia (0.8%), and sepsis (0.8%)
- Permanent discontinuation due to an adverse reaction occurred in 19% of patients. Adverse reactions resulting in permanent discontinuation in ≥2% of patients included COVID-19, Hepatitis E, pneumonitis, and second primary malignancy
- Dosage interruptions due to an adverse reaction occurred in 59% of patients (reactions requiring dosage interruption ≥5%: COVID-19, CRS, pneumonia, upper respiratory tract infection, and fatigue)
- The most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and decreased hemoglobin
- Clinically relevant adverse reactions in <10% of patients included vomiting, pruritus, hepatotoxicity, ICANS, lower respiratory tract infections, cardiac arrhythmias, respiratory tract infections, pneumonitis, second primary malignancy, vision changes, cellulitis, febrile neutropenia, cardiac failure, cytomegalovirus infection, and sepsis
ARs=adverse reactions; ASTCT=American Society for Transplantation and Cellular Therapy; COVID-19=coronavirus disease of 2019; CRS=cytokine release syndrome; CTCAE=common terminology criteria for adverse events; FL=follicular lymphoma; ICANS=immune effector cell-associated neurotoxicity syndrome; NHL=non-Hodgkin lymphoma.
