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FDA Approval of Brentuximab Vedotin for Relapsed or Refractory Large B-Cell Lymphoma
On February 11, 2025, the Food and Drug Administration authorized the use of brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in conjunction with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL originating from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), following two or more lines of systemic therapy for those ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
Effectiveness and Safety
Approval was granted based on ECHELON-3 (NCT04404283), a randomized, double-blind, placebo-controlled trial including 230 adult patients with relapsed or refractory LBCL who were ineligible for auto-HSCT or CAR T-cell treatment. Patients were randomized in a 1:1 ratio to receive either brentuximab vedotin combined with lenalidomide and rituximab (BV+R2) or a placebo combined with lenalidomide and rituximab (Pbo+R2) until disease progression or intolerable toxicity occurred.
The primary effectiveness endpoint was overall survival (OS). Supplementary efficacy outcome metrics encompassed progression-free survival (PFS) and objective response rate (ORR) according to the 2014 Lugano Criteria. The experiment exhibited a statistically significant improvement in overall survival (OS), with a median OS of 13.8 months (95% CI: 10.3, 18.8) in the BV+R2 group compared to 8.5 months (95% CI: 5.4, 11.7) in the Pbo+R2 group (Hazard ratio [HR] 0.63, 95% CI: 0.45, 0.89; p-value 0.0085).
The clinical trial showed a statistically significant enhancement in progression-free survival (PFS) and overall response rate (ORR). The median progression-free survival (PFS) was 4.2 months (95% CI: 2.9, 7.1) for the BV+R2 group and 2.6 months (95% CI: 1.4, 3.1) for the Pbo+R2 group (HR 0.53, 95% CI: 0.38, 0.73; p-value <0.0001). The overall response rate (ORR) was 64.3% (95% confidence interval: 54.7, 73.1) and 41.5% (95% confidence interval: 32.5, 51.0), respectively.
Negative Responses
The predominant adverse responses (≥20%), excluding laboratory abnormalities in the BV+R2 cohort, were fatigue, diarrhea, peripheral neuropathy, rash, pneumonia, and COVID-19 infection. Laboratory abnormalities classified as Grade 3 to 4, occurring in over 10%, included reduced neutrophils, reduced lymphocytes, reduced platelets, and reduced hemoglobin.
Peripheral neuropathy emerged or intensified in 27% of patients, primarily of a sensory nature, resulting in a dose decrease of brentuximab vedotin in 6% and cessation in 4.5%.
The advised dosage of brentuximab vedotin is 1.2 mg/kg, not exceeding 120 mg, in conjunction with lenalidomide and rituximab, to be provided every three weeks until disease progression or intolerable toxicity occurs.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
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