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Brentuximab Vedotin Combination for Relapsed Diffuse Large B-Cell Lymphoma.

Nancy L Bartlett¹, Uwe Hahn², Won-Seog Kim³

¹Division of Oncology, Washington University School of Medicine, Siteman Cancer Center, St Louis, MO.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology

|January 8, 2025

Summary

Brentuximab vedotin plus lenalidomide and rituximab significantly improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. This combination therapy demonstrated a manageable safety profile in heavily pretreated individuals.

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Area of Science:

Hematology
Oncology
Clinical Trials

Background:

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) presents a significant unmet need.
Brentuximab vedotin (BV) has shown prior efficacy in monotherapy or combination regimens for R/R DLBCL.

Purpose of the Study:

To evaluate the efficacy and safety of brentuximab vedotin (BV) in combination with lenalidomide (Len) and rituximab (R) compared to placebo plus Len and R in patients with R/R DLBCL.

Main Methods:

A randomized, double-blind, placebo-controlled, phase 3 trial (ECHELON-3) enrolled 230 patients with R/R DLBCL.
Patients received either BV + Len + R or placebo + Len + R.
Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

Main Results:

Median OS was significantly longer with BV + Len + R (13.8 months) versus placebo + Len + R (8.5 months) (HR, 0.63; P = .009).
Median PFS (4.2 vs 2.6 months; HR, 0.53; P < .001) and ORR (64% vs 42%; P < .001) were also significantly improved with BV combination.
Complete response rates were 40% for BV + Len + R and 19% for placebo + Len + R.

Conclusions:

Brentuximab vedotin plus lenalidomide and rituximab demonstrated a statistically significant survival benefit in heavily pretreated R/R DLBCL patients.
The combination therapy exhibited a manageable safety profile, with similar rates of treatment-emergent adverse events across both arms.