Statistical Analysis
aggressive non-Hodgkin lymphomas, death, tumor, DLBCL
DISEASE PROGRESSION, TUMOR, DISEASE, EVENT, BEST
Enrollment occurred in two stages; 28 patients with DLBCL were enrolled in the first stage. Interim analysis was conducted when approximately 25 patients with DLBCL had follow-up of up to 12 weeks. Futility stopping criteria were not met; therefore, an additional 100 patients with DLBCL were enrolled in the second stage, with up to 30 additional patients having other types of aggressive non-Hodgkin lymphomas.ORR was defined as the proportion of patients who achieved best overall response of CR or partial response (PR). Best overall response per response criteria before initiation of subsequent antilymphoma therapy was summarized. The primary analysis of ORR was IRC-assessed response per Lugano criteria in the full analysis population (all patients who received at least one dose of epcoritamab). The ORR and the corresponding 95% exact CI were calculated.PFS was defined as time from day 1 of cycle 1 to first documented disease progression or death because of any cause, whichever occurred earlier. Patients who remained alive without disease progression at the cutoff date were censored at the date of last evaluable disease assessment before the start of subsequent antilymphoma therapy. For patients who remained alive with incomplete or no baseline tumor assessment, PFS was censored on day 1 of cycle 1.Time-to-event end points (DOR, PFS, and OS) were analyzed using Kaplan-Meier estimates (median time and 95% CI) with the number and percentage of patients with an event or censoring reported. Efficacy analyses were performed on the full analysis set; the safety analysis set was identical to the full analysis set (all patients who received at least one dose of epcoritamab). A landmark analysis was conducted for PFS by MRD status up to cycle 3 day 1 (day 60, considering ± 3-day window). Data were analyzed using SAS software version 9.4 (SAS Institute, Inc, Cary, NC; Data Supplement).