Pfizer has reported promising results from a Phase 3 study of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. Positive outcomes were also observed in key secondary endpoints, including progression-free survival (PFS) and overall response rate (ORR).
The ECHELON-3 trial’s safety and tolerability of ADCETRIS were consistent with previous findings in clinical trials for patients with relapsed/refractory DLBCL. The study, encompassing heavily pre-treated patients, including those who underwent prior CAR-T therapy, showcased encouraging results. DLBCL, the most common type of lymphoma, is a fast-growing, aggressive blood cancer affecting approximately 40% of patients who do not respond to initial treatment or experience relapse.
ADCETRIS, a standard of care for certain lymphomas, has gained approval for seven indications in the U.S., with over 55,000 patients treated since its initial approval in 2011 and over 140,000 patients globally. Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration (FDA) to support potential regulatory filings in the U.S.
ECHELON-3 is an ongoing Phase 3 study comparing ADCETRIS plus lenalidomide and rituximab to lenalidomide and rituximab plus placebo in adult patients with relapsed/refractory DLBCL, regardless of CD30 expression, who are ineligible for stem cell transplant or CAR-T therapy. The study, spanning North America, Europe, and Asia-Pacific, includes 230 randomized patients.
Diffuse large B-cell lymphoma (DLBCL) is a challenging-to-treat, aggressive lymphoma, accounting for over 25,000 cases annually in the United States. Up to 40% of patients experience relapse or refractory disease after initial treatment.
Pfizer and Takeda jointly develop ADCETRIS, with commercialization rights divided between the two companies. The positive results from ECHELON-3 represent a significant advancement in addressing the unmet needs of patients with relapsed or refractory DLBCL.