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New Analyses Presented at ASCO Reaffirmed Efficacy and Safety of TORISEL in Patients With Advanced Kidney Cancer
Date:5/31/2008

- Data Showed Overall Survival Benefit With TORISEL Regardless of Nephrectomy Status; Additional Analysis Examined Specific Side Effects -

COLLEGEVILLE, Pa., May 31 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced results of two new analyses of the pivotal study of the mTOR (mammalian target of rapamycin) inhibitor TORISEL(R) (temsirolimus), the only renal cancer therapy proven to extend median overall survival compared with interferon-alpha in patients with advanced renal cell carcinoma (RCC). These analyses, which are being presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, reaffirm the efficacy and safety of TORISEL for the treatment of advanced RCC. TORISEL is the only approved cancer therapy that specifically inhibits the mTOR kinase, an important regulator of cell proliferation, cell growth and cell survival.

RCC will account for approximately 85 percent of renal cancers. There are an estimated 54,390 new cases of kidney and renal pelvis cancer diagnosed in the United States each year, and about 40 percent of patients have advanced disease at the time of diagnosis.

TORISEL was studied in a three-arm, phase 3 clinical trial of 626 patients with advanced RCC with three or more of six preselected prognostic risk factors who had received no prior systemic therapy. Results of this study demonstrated that TORISEL significantly increased median overall survival by 49 percent compared with interferon-alpha (10.9 months [95% CI: 8.6, 12.7] vs. 7.3 months [6.1, 8.8], P=0.0078) (Hazard Ratio [95% CI] = 0.73 [0.58, 0.92]).

"In summary, these analyses provide clinicians with additional information about the efficacy an
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SOURCE Wyeth Pharmaceuticals
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