Multinational phase 3 trial of brentuximab vedotin, lenalidomide and rituximab for relapsed or refractory diffuse large B-cell lymphoma

The multinational phase 3 ECHELON-3 trial evaluated addition of brentuximab vedotin (BV) tot lenalidomide (Len) and rituximab (R) for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Patients were randomized to BV + Len + R or placebo + Len + R. The primary end point was overall survival. Median overall survival was 13.8 months in the BV group versus 8.5 months in the placebo group (HR 0.63; p=0.009), with OS profit from BV in almost all patient subgroups. Median progression-free survival was 4.2 months versus 2.6 months (HR 0.53; p<0.001), the objective response rate was 64% versus 42%, and the complete response rate was 40% versus 19%. Treatment-related adverse events occurred in 97% of patients in both groups. The authors conclude that addition of BV to Len + R resulted in a statistically significant survival benefit with a manageable safety profile in patients with R/R DLBCL.