Brentuximab Vedotin Plus Lenalidomide and Rituximab Improves Survival For Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Brentuximab vedotin (BV) combined with lenalidomide and rituximab demonstrated improved survival rates and a favorable safety profile for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), compared with placebo combined with lenalidomide and rituximab, according to results from the phase 3 ECHELON-3 trial.

Previous studies have shown efficacy of brentuximab vedotin in combination with either lenalidomide or rituximab for R/R DLBCL. Researchers conducted a randomized, double-blind, placebo-controlled, multicenter, phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin combined with lenalidomide and rituximab versus placebo plus lenalidomide and rituximab.

The primary end point was overall survival (OS), and secondary end points included investigator-assessed progression-free survival (PFS) and objective response rate (ORR). Patients (n = 230) were randomly assigned to receive brentuximab vedotin combined with lenalidomide and rituximab (n = 112) or placebo (n = 118). The median follow-up was 16.4 months, the median OS was higher for patients treated with brentuximab vedotin combined with lenalidomide and rituximab (13.8 months), than patients who received placebo (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.45 to 0.89; P = .009).

Additionally, the median PFS was higher for patients treated with brentuximab vedotin combined with lenalidomide and rituximab (4.2 months), compared with placebo (2.6 months; HR, 0.53; 95% CI, 0.38 to 0.73; P < .001). The ORR was also higher with brentuximab vedotin combined with lenalidomide and rituximab (64%; 95% CI, 55 to 73; P < .001) compared with (42%; 95% CI, 33 to 51), with complete response rates of 40% and 19%, respectively.

Treatment-emergent adverse events occurred in 97% of all patients. The most common included neutropenia, thrombocytopenia, diarrhea, and anemia.

"BV + Len + R [brentuximab vedotin plus lenalidomide plus rituximab] demonstrated a statistically significant survival benefit with a manageable safety profile in heavily pretreated patients with R/R DLBCL," the researchers concluded.

Source:

Bartlett NL, Hahn U, Kim WS, et al. Brentuximab Vedotin Combination for Relapsed Diffuse Large B-Cell Lymphoma. Journal of Clinical Oncology. Published online January 7, 2025. doi: 10.1200/jco-24-02242