NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE) announced today that the Phase 3 ECHELON-3 clinical trial of ADCETRIS (brentuximab vedotin), in combination with lenalidomide and rituximab, has shown a significant improvement in overall survival for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study also reported positive outcomes in progression free survival and overall response rate compared to a control group receiving lenalidomide and rituximab plus placebo.
The trial included patients who had received two or more prior lines of therapy and were ineligible for stem cell transplant or CAR-T therapy. The safety profile of ADCETRIS was consistent with previous findings in the patient population with DLBCL.
DLBCL is a rapidly progressing and aggressive form of blood cancer, representing the most common type of lymphoma. Approximately 40% of DLBCL patients do not respond to initial treatment or relapse after first-line treatment.
ADCETRIS is currently approved for seven indications in the U.S., with over 55,000 patients treated since its first approval in 2011. Globally, more than 140,000 patients have been treated with the drug. Pfizer plans to discuss the ECHELON-3 trial data with the U.S. Food and Drug Administration (FDA) for potential regulatory submission, which could lead to the eighth indication for ADCETRIS.
The ECHELON-3 trial is a randomized, double-blind, multicenter study conducted across North America, Europe, and Asia-Pacific. The primary endpoint was overall survival in the intent-to-treat population. Secondary endpoints included progression free survival, overall response rate, complete response rate, duration of response, and safety and tolerability.
Pfizer Oncology, known for its extensive portfolio and pipeline, is committed to providing transformative therapies for prevalent cancers, including DLBCL. The company's approach includes a variety of mechanisms, such as antibody-drug conjugates, small molecules, and immunotherapy biologics.
The results of the ECHELON-3 trial are expected to be presented at an upcoming medical meeting, and the full data will be submitted for consideration. This press release is based on a press release statement and contains forward-looking information subject to risks and uncertainties.
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