Phase 3 Success: ADCETRIS® Prolongs Survival in Relapsed/Refractory DLBCL

A recent Phase 3 clinical trial has demonstrated the efficacy of ADCETRIS® (brentuximab vedotin) combined with lenalidomide and rituximab in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study, known as ECHELON-3, revealed significant improvements in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). The safety profile of ADCETRIS in the trial was consistent with previous findings, and the detailed results are expected to be presented at an upcoming medical conference.

Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer, highlighted the significance of these results, especially considering the study included heavily pre-treated patients, some of whom had undergone CAR-T therapy before. DLBCL is an aggressive blood cancer that is the most common type of lymphoma, with approximately 40% of patients either not responding to initial treatments or experiencing a relapse after first-line treatments.

ADCETRIS is an antibody-drug conjugate that has been a standard of care for certain lymphoma patients and has been approved for seven indications in the U.S., with over 55,000 patients treated since its initial approval in 2011. Pfizer is planning to discuss the ECHELON-3 data with the FDA, which could potentially lead to an eighth indication for ADCETRIS.

The ECHELON-3 trial was a global, randomized, double-blind study involving 230 adult patients with relapsed/refractory DLBCL who had received at least two prior treatments and were not eligible for stem cell transplant or CAR-T therapy. The primary goal was to evaluate OS, with secondary goals including PFS, ORR, and other measures of safety and tolerability.

ADCETRIS is developed jointly by Pfizer and Takeda, with Pfizer holding the rights to commercialize the drug in the U.S. and Canada, while Takeda has the rights for the rest of the world. The companies share development costs equally, except in Japan where Takeda is solely responsible.

ADCETRIS has a boxed warning for progressive multifocal leukoencephalopathy (PML), a serious brain infection that can be fatal, and is contraindicated with concomitant bleomycin due to increased pulmonary toxicity. Other warnings include peripheral neuropathy, anaphylaxis and infusion reactions, hematologic toxicities, serious infections, tumor lysis syndrome, and increased toxicity in patients with severe renal or hepatic impairment. There are also precautions related to hepatotoxicity, pulmonary toxicity, serious dermatologic reactions, gastrointestinal complications, hyperglycemia, and embryo-fetal toxicity.

Pfizer Oncology is at the forefront of developing new cancer therapies, with a portfolio that includes antibody-drug conjugates, small molecules, bispecific antibodies, and other immunotherapy biologics. Pfizer is dedicated to delivering transformative treatments for common cancers and improving patient outcomes.