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Investigators from Weill Medical College of Cornell University today reported encouraging interim results with a new potential therapy for non-Hodgkin's lymphoma (NHL), which affects about 53,900 new patients each year in the United States. The presentation was made at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, FL.

Dr. John P. Leonard, the lead investigator of a trial involving a collaboration of scientists from Weill Cornell, Amgen (of Thousand Oaks, CA), and Immunomedics (of Morris Plains, NJ), reported data from 21 patients who have relapsed and refractory NHL—patients in whom the disease has progressed despite prior treatment. The study is the first trial of a combination of two monoclonal antibodies in lymphoma—one of the antibodies a known agent (rituximab) and the other a new one (epratuzumab). Administered together, once weekly for four weeks, the combination has preliminarily shown enhanced efficacy over that which has been previously reported with rituximab alone.

Rituximab acts against the CD20 antigen (or target molecule) on NHL cells. Its brand name is Rituxan®, and it is produced by IDEC, of San Diego, Calif., and Genentech, of San Francisco. Epratuzumab, a new investigational antibody in development by Amgen and Immunomedics, acts against the CD22 antigen of NHL.

The findings show that NHL patients with the indolent form of the disease, which afflicts about 45% of the 300,000 patients alive with this disease in the U.S., had an overall objective response (partial and complete responses combined) of 63% (10 of 16 patients), with 9 of these responders having a complete response, or complete remission.

"This combination antibody treatment program resulted in a complete response rate of 56%, which is the highest yet reported in lymphoma with any form of antibody therapy," commented Dr. Leonard, who is an Assistant Professor of Medicine in the Division of Hematology/Oncology of the Department of Medicine at Weill Cornell Medical College, and Clinical Director of the Center for Lymphoma and Myeloma at NewYork-Presbyterian Hospital's Weill Cornell Medical Center. "Although the findings are only preliminary—with up to 16 months after treatment—the responding patients all have remained in remission."

Clinical responses were also observed in patients with more aggressive NHL subtypes as well. The report also noted that no significant additional toxicity was apparent with the antibody combination, which is in contrast to the frequent side effects observed in patients receiving many other cancer treatments.

Dr. Morton Coleman, Director of Weill Cornell's Center for Lymphoma and Myeloma and a co-investigator in the study, stated, "The promising initial results observed in this trial offer hope for a potential improvement in outcome for lymphoma patients while providing an alternative to chemotherapy. It also represents the first clinical trial combining separate antibodies with distinct targets in NHL therapy." In an overview talk presented at ASCO, Dr. Coleman highlighted the promise of this new antibody approach to the treatment of lymphoma, which is a major focus of the lymphoma program at Weill Cornell.

Besides Drs. Leonard and Coleman, the other authors of the presentation are Jamie C. Matthews, Jennifer M. Fiore, Alan Dosik, Tsiporah Shore, Heather Kapushoc, Michael Macri, William A. Wegener, Alessandra Cesano, and David M. Goldenberg.

The ASCO abstract number is 1060. The poster session for this presentation is from 8:00 a.m. to 12:00 noon on Monday, May 20, in Room 308A of the Orange County Convention Center.