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Brentuximab vedotin in combination with lenalidomide and rituximab receives U.S. FDA approval for the treatment of R/R LBCL
On February 11, 2025, it was announced that the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) in combination with lenalidomide (Len) and rituximab (R), for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after ≥2 lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptors (CAR) T-cell therapy.1 This approval was based on positive results from the phase III ECHELON-3 (NCT04404283) trial.1
ECHELON-3 trial
ECHELON-3 is a randomized, double-blind, placebo (Pbo)-controlled, phase III trial evaluating the efficacy and safety of BV+Len+R vs Pbo+Len+R in patients with R/R LBCL who received ≥2 prior lines of systemic therapy and were ineligible to receive an auto-HSCT or CAR T-cell therapy. Among the intention-to-treat population (n = 230):1,2
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The trial met its primary endpoint of overall survival (OS).
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The median OS was 13.8 months (95% confidence interval [CI] 10.3–18.8) vs 8.5 (95% CI, 5.4–11.7) months in the BV+Len+R vs Pbo+Len+R arms (p = 0.0085).
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The median progression-free survival was longer with BV+Len+R vs Pbo+Len+R, at 4.2 months (95% CI, 2.9–7.1) vs 2.6 months (95% CI, 1.4–3.1); p <0.0001.
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Overall response rates were higher with BV+Len+R vs Pbo+Len+R, at 64.3% (95% CI, 54.7–73.1) vs 41.5% (95% CI, 32.5–51.0).
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Excluding laboratory abnormalities, the most common adverse events reported in ≥20% of patients in the BV+Len+R arm were fatigue, diarrhea, peripheral neuropathy, rash, pneumonia, and COVID-19 infection. Grade 3–4 laboratory abnormalities (observed in >10%) were decreased neutrophils, lymphocytes, platelets, and hemoglobin. Peripheral neuropathy development or worsening was reported in 27% of patients and was predominantly sensory and led to BV dose reduction in 6% and discontinuation in 4.5%.
The recommended BV dose is 1.2 mg/kg up to a maximum of 120 mg in combination with Len and R to be administered every three weeks until disease progression or unacceptable toxicity.
References
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