To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ICML: Bexxar Halts Progression Of Non-Hodgkin's Lymphoma, Study Shows URL: http://www.pslgroup.com/dg/104732.htm Doctor's Guide June 7, 1999
SOUTH SAN FRANCISCO, CA -- June 7, 1999 -- Follow-up data on non-Hodgkin's lymphomoa (NHL) patients treated with Coulter Pharmaceutical, Inc.'s Bexxar(TM) (tositumomab and iodine I 131 tositumomab) show that over half of patients receiving the drug were free of disease progression. The long-term follow-up data from patients treated in all of the company's clinical trials were presented on Saturday by Nancy Valente, M.D., associate director of clinical research at Coulter Pharmaceutical, at the International Conference on Malignant Lymphoma held in Lugano, Switzerland. Dr. Valente said that Bexxar has been administered to 432 NHL patients at approximately 40 centres throughout the United States and United Kingdom. Most of these patients were heavily pre-treated with a median of three prior chemotherapy regimens. At the time of the analysis, 249 of the 432 patients (58 percent) were free of disease progression. Dr. Valente also reported that subsequent therapies have been administered following Bexxar treatment and that generally neither the low blood counts nor HAMA positive readings associated with Bexxar precluded patients from receiving other therapies. Of the 432 patients, 183 had progressed following Bexxar treatment at the time of this analysis. One-hundred-fifty-six of the 183 patients who progressed received greater than 300 subsequent therapies, including re-treatment with Bexxar, single agent or combination chemotherapy, radiation therapy, Rituximab, bone marrow or stem cell transplant, biological therapy and/or steroid therapy. The majority of patients (101 patients or 65 percent) went on to receive chemotherapy following Bexxar. The chemotherapy regimens included combination and salvage therapies such as ESHAP, DHAP, and FND. Twenty patients (13 percent) were re-treated with Bexxar. Fifteen patients (10 percent) underwent stem cell or bone marrow transplants. Forty-one patients (25 percent), six of whom were known to be HAMA positive, received Rituximab as a subsequent therapy. There was no correlation between HAMA positivity and either infusion reaction or response to Rituximab. Twenty-five of the 183 patients were not treated with subsequent therapy primarily due to slowly progressive disease not requiring therapy. Only one patient did not receive subsequent therapy due to low blood counts. Short-term side effects associated with Bexxar included a decrease in blood counts which were generally reversible and self-limiting. Only five percent of patients experienced platelet counts less than 10,000 cells/mm(3), with a minority of patients requiring support by blood cell transfusion of growth factor. Additional short term side effects included a mild to moderate flu-like syndrome which was observed in approximately one-third of patients. Longer-term side effects were infrequent and included increases in thyroid stimulating hormone (TSH) in a small percentage of patients. Myelodysplastic syndrome also was noted in a small percentage of patients for which the cytogenetics of analysed cases were generally consistent with previous exposure to chemotherapeutic agents, such as alkylating agents or etoposide. Human anti-mouse antibodies (HAMA) were detected in nine previously treated patients (six percent). As expected, a higher HAMA rate was observed in previously untreated patients with 35 patients (54 percent) of this patient population testing positive for this laboratory test. Bexxar is currently under investigation for the treatment of low-grade and transformed low-grade NHL. Bexxar, which is an antibody conjugated to iodine 131, attaches to a protein found only on the surface of B-cells, including both non-Hodgkin's lymphoma B-cells and some normal B-cells. Bexxar is believed to work through a dual mechanism of action resulting from the immune system activity of the monoclonal antibody and the therapeutic effects of the iodine (I-131) radioisotope. Through Bexxar's targeted approach, the tumour cells receive a greater concentration of the therapeutic radiation from the therapy relative to normal tissues. Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics form the National Cancer Institute, approximately 300,000 people are afflicted with NHL in the United States alone. Of the total, the company estimates that approximately 140,000 people have low-grade or transformed low-grade disease. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.