Background
Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who relapse after or are ineligible for hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy generally have poor outcomes. Preclinical data support the combination of brentuximab vedotin (BV), lenalidomide (len), and rituximab for treating R/R DLBCL, showing promising clinical activity in a Phase 1 trial.
Methods
The ECHELON-3 study (NCT04404283) is a randomized, double-blind, placebo-controlled, active-comparator, multicenter Phase 3 study. An open-label safety run-in was conducted prior to randomization, where patients received BV (1.2 mg/kg) and rituximab (375 mg/m2) every three weeks, and len 20 mg daily. Eligible patients had received at least two prior lines of therapy, were previously treated with or ineligible for HSCT or CAR-T, had an ECOG score of 2 or less, and had PET-avid, bidimensional measurable disease.
Results
Ten patients with R/R DLBCL were enrolled, with a median age of 70.5 years. At a median follow-up of 6.9 months, the most common treatment emergent adverse events were fatigue, anemia, and constipation. Grade 3 or higher events were experienced by 8 patients, with serious adverse events observed in 7 patients. The overall response rate was 70%, including complete and partial metabolic responses. Responses were observed in both CD30 positive and negative patients, as well as in those who had received prior CAR-T therapy.
This study underscores the potential efficacy of combining BV, len, and rituximab for treating R/R DLBCL, offering hope for patients with limited treatment options.
