Safety
neutropenia, Febrile neutropenia, COVID-19 disease, hepatotoxicity, loss of consciousness, CRS, chronic lymphocytic inflammation
PULMONARY EMBOLISM, MYOCARDIAL INFARCTION, NEUTROPENIA, CLINICAL TUMOR LYSIS SYNDROME, FEBRILE NEUTROPENIA, EVENT, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, CHRONIC LYMPHOCYTIC INFLAMMATION, EVENTS
Treatment-emergent AEs observed with epcoritamab are summarized in Table Treatment-Emergent AEs by Worst Grade During the Treatment Period in Patients With LBCLTreatment-emergent AEs leading to discontinuation occurred in 12 patients (7.6%); three patients discontinued because of treatment-related AEs, including worsening of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (see the description in the Data Supplement), CRS, and ICANS (one patient each). Nine patients (5.7%) had fatal treatment-emergent AEs, including COVID-19 disease in two patients and one case each with myocardial infarction, hepatotoxicity, progressive multifocal leukoencephalopathy, loss of consciousness, general health deterioration, pulmonary embolism, and ICANS. None of these AEs were considered related to epcoritamab by the investigator, except for the one fatal ICANS event, which had multiple concurrent confounding factors (Data Supplement). ICANS events occurred in 10 (6.4%) patients, including seven patients with grade 1, two patients with grade 2, and one fatal event. At least one event of CRS was observed in 49.7% of patients, mostly grade 1 in severity (n = 50; grade 2: n = 24; grade 3: n = 4); no grade 4 or 5 events were observed. Most CRS events occurred after the first full dose (Data Supplement) on day 15 of cycle 1 with a median time to onset of 0.8 days (20 hours). CRS resolved in 77 of 78 patients (98.7%); the median time to resolution from onset after first full dose was 2 days (48 hours). CRS was treated with tocilizumab in 22 (28.2%) patients and with corticosteroids (beyond those required for CRS prophylaxis) in 16 (20.5%) patients. Clinical tumor lysis syndrome occurred in two patients (grade 3 in severity) and was considered related to treatment. COVID-19–related events occurred in 10 (6.4%) patients; two of these cases were fatal but deemed to be unrelated to treatment.The overall incidence of neutropenia was 21.7% (34 of 157). Febrile neutropenia was observed in four patients (2.5%) and was considered treatment-related in one patient (0.6%). Treatment with granulocyte colony-stimulating factor was required in 16 patients (10.2%).