• The combination of brentuximab vedotin and lenalidomide is active in relapsed/refractory DLBCL with a favorable safety profile.

  • A phase III study is currently enrolling to investigate the efficacy of this regimen in combination with rituximab.

New therapies are needed for patients with relapsed/refractory (rel/ref) diffuse large B-cell lymphoma (DLBCL) who do not benefit from or are ineligible for stem cell transplant and chimeric antigen receptor therapy. The CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) and the immunomodulator lenalidomide (Len) have demonstrated promising activity as single agents in this population. We report the results of a phase I/dose expansion trial evaluating the combination of BV/Len in rel/ref DLBCL. Thirty-seven patients received BV every 21 days with Len dosed continuously for a maximum of 16 cycles. The maximum tolerated dose of the combination was 1.2 mg/kg BV with 20 mg/day Len. BV/Len was well tolerated with a toxicity profile consistent with their use as single agents. Most patients required G-CSF support due to neutropenia. Overall response rate (ORR) was 57% (95% CI: 39.6-72.5%), complete response rate 35% (95% CI: 20.7-52.6%), median duration of response 13.1 months, median progression-free survival 10.2 (95% CI: 5.5-13.7) months and median overall survival 14.3 months (95% CI 10.2-35.6). Response rates were highest in patients with CD30+ DLBCL (73%) but did not differ according to cell of origin (p=0.96). NK cell expansion and phenotypic changes in CD8+ T-cell subsets in non-responders were identified by mass cytometry. BV/Len represents a potential treatment option for patients with rel/ref DLBCL. This combination is being further explored in a phase III study (NCT04404283). Current trial registered at www.clinicaltrials.gov (NCT02086604).

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