About The Trial
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (ECHELON-3)
Sponsor: Seagen Inc
ClinicalTrials.gov ID: NCT04404283
Completion Date (Estimated): April 2027
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Brentuximab Vedotin Shows 37% Reduction in Risk of Death for DLBCL
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Brentuximab vedotin in combination with lenalidomide and rituximab had a favorable safety profile for patients with relapsed/refractory diffuse large B-cell lymphoma.
Brentuximab vedotin (Adcetris; Pfizer) in combination with lenalidomide (Revlimid; Bristol Myers Squibb) and rituximab (Rituxan; Genentech, Biogen) showed a 37% reduction in the risk of death compared with placebo in combination with lenalidomide and rituximab for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to findings from the ECHELON-3 study.
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“ECHELON-3 is one of the first randomized, placebo-controlled phase 3 studies to demonstrate an overall survival [(OS)] benefit in patients with [R/R] DLBCL after 2 or more prior lines of systemic therapy,” Jeung-A Kim, MD, of the College of Medicine at The Catholic University of Korea, said in the press release. “The clinically meaningful improvement in survival demonstrates the potential benefit of this [brentuximab vedotin] regimen in [R/R] DLBCL, particularly for patients whose disease has progressed after CAR-T therapy or bispecific antibody treatment or individuals who are not able to receive these treatments.”1
Investigators included patients with R/R DLBCL who had received 2 or more lines of systemic therapy prior to inclusion in the study. Further, individuals needed to be hematopoietic stem cell transplantation (HSCT) or CAR-T ineligible with 1 or more co-morbidities, active disease following induction, inadequate stem cell mobilization, relapse following HSCT or CAR-T, or unable to receive CAR-T therapy. Patients were excluded if they had a history of another malignancy within 2 years before the first dose of the study drug, had history of progressive multifocal leukoencephalopathy, had active cerebral/meningeal disease related to the malignancy, or uncontrolled grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the study.2
In the experimental arm, investigators received brentuximab vedotin 1.2 g/kg administrated intravenously (IV) every 3 weeks, rituximab 375 mg/m2 administered via IV on cycle 1 day 1, then 1400 mg subcutaneously ever 3 weeks from cycle 2 day 1 to end of treatment, and lenalidomide 20 mg given orally daily. In the control arm, the dosing schedule was the same, except the investigators administered the placebo instead of brentuximab vedotin.2
The primary outcome was overall survival (OS), and the secondary end points included progression-free survival (PFS), objective response rate (ORR), complete response (CR), duration of response, incidence of adverse events (AEs), and OS for individuals with CD30-positive disease.2
Among 230 individuals included in the study, the OS was 13.8 months for the brentuximab vedotin combination compared with 8.5 months for those with the placebo combination. Median PFS was 4.2 months and 2.6 months in the combination arm and placebo arm, respectively, and the ORR was 64.3% and 41.5%. CR was found for approximately 40.2% of individuals in the brentuximab vedotin combination group compared with 18.6% in the placebo group.1
The most frequently reported treatment-emergent AEs that were grade 3 or higher in the brentuximab vedotin arm and the placebo arm were neutropenia (43% vs 28%), thrombocytopenia (25% vs 19%), and anemia (22% vs 21%). Investigators reported that peripheral sensory neuropathy was infrequent, with low grade events of 4% and 0%, respectively.1
References
1. Pfizer’s Adcetris Regimen Produces Clinically Meaningful Improvement in Overall Survival in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL). News release. Pfizer. June 1, 2024. Accessed June 10, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-adcetrisr-regimen-produces-clinically-meaningful
2. Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (ECHELON-3). Seagen Inc. ClinicalTrials.gov identification: NCT04404283. June 4, 2024. Accessed June 10, 2024. https://clinicaltrials.gov/study/NCT04404283
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