Press Release

For Immediate Release

JAMES C. YANG TO PRESENT CANCER STUDY AT SBT MEETING IN SAN DIEGO

Milwaukee-James C. Yang will present “A 3-arm randomized comparison of high and low dose intravenous and subcutaneous interleukin-2 in the treatment of metastatic renal cancer,” an abstract on research conducted by James C. Yang and Steven A. Rosenberg, Surgery Branch, National Cancer Institute-National Institutes of Health at the 17th Annual Meeting of the Society for Biological Therapy (SBT) which is being held November 7-10, 2002 at the Hilton La Jolla Torrey Pines in La Jolla/San Diego, California. Pre-registration for the meeting is available until October 23, 2002. Onsite registrations will also be accepted.

A 3-arm randomized comparison of high and low dose intravenous and subcutaneous interleukin-2 in the treatment of metastatic renal cancer.
James C. Yang and Steven A. Rosenberg, Surgery Branch, NCI.

High-dose interleukin-2 (IL-2) is the only therapy currently approved for the treatment of advanced renal cell cancer (RCC) but IL-2 is frequently given at lower doses to avoid side-effects. This study compared patients with metastatic renal cancer, randomly assigned to receive high-dose (HD) intravenous, low-dose (LD) intravenous or low-dose daily subcutaneous (SC) IL-2 to determine if there were differences in response rates or overall survival. Initially only high and low dose intravenous IL-2 were compared, but after randomizing 117 patients, a third randomly-assigned treatment group receiving daily SC IL-2 was added due to the frequency with which this therapy was being used by physicians to treat renal cancer. At study completion, a total of 156 patients were randomized to HD and 150 to LD intravenous IL-2 and 94 to outpatient subcutaneous IL-2. Toxicities were significantly lower with LD i.v. IL-2 and subcutaneous IL-2, especially low blood pressure requiring ICU support, but there were no IL-2-related deaths in any of the 400 enrolled patients. There was a statistically significantly higher response rate (consisting of at least a 50% decrease in the net size of measured tumors) with HD i.v. IL-2 (21% of patients) versus LD i.v. IL-2 (13% of patients) and a trend toward more durable responses with HD. There was a similar difference in response rates for the 94 patients assigned to SC IL-2 (10% responded) and the 96 patients who were assigned to HD IL-2 after the third patient group was added (21% of those patients responded). There were no significant differences in overall survival between patient groups. These response rates for two identical IL-2 regimens differing only in dose, indicate that IL-2 is more active at maximally tolerated doses, but with only a minority of patients benefiting, the groups as a whole did not show different survivals in this study.

Additional SBT meeting features of this cutting-edge scientific meeting include sessions on Antibodies/Immunoconjugates, Engineered T Cells and IL-2 in Malignancy, Vaccines & Mechanisms of Escape, Angiogenesis, Cytokines, New Therapies/Novel agents and Immune Monitoring. More information about the Society for Biological Therapy (SBT) may be found at www.isbtc.org.

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Editor’s Note: Members of the Press may register without charge for the SBT Annual Meeting. To receive an Annual Meeting Program or registration materials, please contact Laura Kalies via E-mail: lkarec@isbtc.org, Phone: 414/278-8541, or Fax: 414/278-3801.

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