Brentuximab Vedotin (Adcetris) Combination Now FDA-Approved for R/R LBCL Patients Ineligible for Transplant or CAR-T

Posted: Feb 13, 2025

Treatment Advances

On February 11th, 2025, the U.S. Food and Drug Administration (FDA) approved a new combination treatment for adult patients with relapsed/refractory large B-cell lymphoma (LBCL).

This treatment, consisting of brentuximab vedotin, lenalidomide, and rituximab, offers a new option for patients who have exhausted at least two other lines of therapy and are unable to receive an autologous stem cell transplant or CAR T-cell therapy due to barriers such as additional health conditions, travel restrictions, insurance issues, or manufacturing barriers.

Previously approved as individual therapies, the combination of brentuximab vedotin (Adcetris, Pfizer), lenalidomide (Revlimid, BMS), and rituximab (Rituxan, Genentech) demonstrated positive results in the ECHELON-3 study, leading to the regimen’s approval for LBCL treatment.

ECHELON-3 Results Support the Approval of Brentuximab Vedotin Combination for Relapsed/Refractory LBCL

In this study, 230 patients with relapsed/refractory LBCL who had been treated with at least two prior therapies were assigned to receive one of the below treatment combinations. They continued receiving the study regimen unless the cancer progressed or if the side effects outweighed the benefits of the treatment.

The main findings from the trial included:

	Patients who received brentuximab vedotin with lenalidomide and rituximab	Patients who received a placebo with lenalidomide and rituximab
Overall response rate (percentage of patients who experienced a partial or full reduction of cancer cells following treatment)	64.3%	41.5%
Average progression-free survival (amount of time the cancer did not progress since the start of treatment)	4.2 months	2.6 months
Average overall survival (amount of time patients were alive since the start of treatment)	13.8 months	8.5 months

Common side effects patients experienced from the brentuximab vedotin combination included fatigue, diarrhea, peripheral neuropathy (tingling or pain of nerves affecting areas like hands/feet), rash, pneumonia, and low blood cell counts. If you have concerns regarding how these side effects can be managed with supportive care, please speak with your LBCL specialist.

“Patients with large B-cell lymphoma can face a challenging journey, with too many patients enduring multiple rounds of chemotherapy and even CAR-T therapy with limited success. For patients who have previously faced setbacks with other therapies, ADCETRIS provides a new therapeutic option with outpatient administration and proven safety and efficacy.” -Dr. Craig Portell, Associate Professor, University of Virginia.

Summary

The FDA's recent approval of the combination therapy involving brentuximab vedotin, lenalidomide, and rituximab provides a promising new treatment option for patients with relapsed/refractory large B-cell lymphoma who face barriers to receiving an autologous stem cell transplant or CAR T-cell therapy.

Demonstrating a 37% reduction in the risk of death compared to a regimen of lenalidomide, rituximab, and placebo, this therapy underscores the efficacy of brentuximab vedotin. With this being its eighth FDA approval, brentuximab vedotin is establishing itself as a standard of care for patients with lymphoma.

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ECHELON-3 Results Support the Approval of Brentuximab Vedotin Combination for Relapsed/Refractory LBCL

The main findings from the trial included:

	Patients who received brentuximab vedotin with lenalidomide and rituximab	Patients who received a placebo with lenalidomide and rituximab
Overall response rate (percentage of patients who experienced a partial or full reduction of cancer cells following treatment)	64.3%	41.5%
Average progression-free survival (amount of time the cancer did not progress since the start of treatment)	4.2 months	2.6 months
Average overall survival (amount of time patients were alive since the start of treatment)	13.8 months	8.5 months

“Patients with large B-cell lymphoma can face a challenging journey, with too many patients enduring multiple rounds of chemotherapy and even CAR-T therapy with limited success. For patients who have previously faced setbacks with other therapies, ADCETRIS provides a new therapeutic option with outpatient administration and proven safety and efficacy.” -Dr. Craig Portell, Associate Professor, University of Virginia.