COLLEGEVILLE, Pa., May 30 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , today announced the publication of the pivotal phase 3 study of TORISEL(TM) (temsirolimus), a newly approved therapy for the treatment of advanced renal cell carcinoma (RCC), in the May 31, 2007, issue of The New England Journal of Medicine. These newly published data showed that weekly doses of TORISEL 25 mg I.V. significantly improved median overall survival for patients with advanced RCC and poor prognosis, compared WITH interferon-alpha, a widely used treatment.
Renal cell carcinoma accounts for approximately 85 percent of kidney cancers. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40 percent of patients will be diagnosed initially with advanced disease.
Results of the open-label phase 3 study showed that patients treated with TORISEL had a 49 percent improvement in median overall survival versus those patients treated with interferon-alpha, an active comparator (10.9 months vs. 7.3 months, P=.008).
TORISEL, which was approved by the U.S. Food and Drug Administration on May 30, 2007, for the treatment of advanced RCC, is the only targeted therapy proven to extend overall survival for these patients. TORISEL is a novel anticancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Torisel is the first mTOR inhibitor approved for the treatment of advanced kidney cancer.
“Patients with advanced renal cell carcinoma and poor prognosis have tumors that are particularly difficult to treat, and few studies have examined therapeutic approaches specifically for these patients,” says Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, and lead author. “This study demonstrates that temsirolimus is efficacious in these poor-prognosis patients.”
Study Results
This open-label, randomized, phase 3 trial compared TORISEL alone or a combination of TORISEL plus interferon-alpha to interferon-alpha alone. The study included 626 patients with advanced RCC who had received no prior systemic therapy and had at least three of six prespecified risk factors for poor prognosis and shortened survival. The primary endpoint of the study was overall survival. Secondary endpoints included progression-free survival as determined by both investigator assessment and an independent radiologic review.
Based on investigator assessment, progression-free survival doubled in patients treated with TORISEL compared with interferon-alpha alone (3.8 months vs. 1.9 months, P<.001). Based on independent assessment, progression-free survival was 5.5 months and 3.1 months, respectively (P<.007). Progression- free survival, or the length of time patients remained alive without worsening of their disease, was significantly longer among patients treated with TORISEL alone than those treated with interferon-alpha alone, whether determined by the study investigators or by an independent radiology review.
The use of TORISEL and interferon-alpha in combination is not recommended. Median overall survival time in patients treated with the combination of TORISEL and interferon-alpha was not statistically different than interferon- alpha, and the combination was associated with a greater incidence of serious adverse events.
About Renal Cell Carcinoma
The global incidence of kidney cancer has increased by 2 percent each year for unknown reasons. The incidence of the disease is highest among people between the ages of 50 to 70, and it affects nearly twice as many men as women.
A number of risk factors have been identified that can help predict outcome in patients with advanced RCC. Based on the number of prognostic risk factors present prior to the beginning of treatment, physicians can classify patients with advanced RCC as having favorable, intermediate or poor prognosis. In one analysis, patients with poor prognosis lived less than one- third as long as those classified as having intermediate prognosis and about one-sixth as long as those classified as having favorable prognosis.
About TORISEL
TORISEL is an mTOR inhibitor indicated for the treatment of advanced RCC. In cancer cells, mTOR inhibition may block the translation of genes that regulate the cell cycle. mTOR inhibition also may restrict the over-expression of cell growth factors involved in the development of new vessels to provide blood to tissue.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but not limited to anaphylaxis, dyspnea, flushing, and chest pain have been observed with Torisel.
The use of Torisel is likely to result in increases in serum glucose. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy.
The use of Torisel may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections. Live vaccinations and close contact with those who received live vaccines should be avoided. Due to abnormal wound healing, use Torisel with caution in the perioperative period.
Cases of interstitial lung disease, some resulting in death, have occurred with Torisel. Some patients were asymptomatic and others presented with symptoms and required discontinuation of Torisel treatment and/or corticosteroids, and/or antibiotics.
The use of Torisel is likely to result in increases in serum triglycerides and cholesterol. This may require initiation, or increase in the dose, of lipid-lowering agents.
Bowel perforation may occur. Evaluate fever, abdominal pain, bloody stools and/or acute abdomen promptly. Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on Torisel.
Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant.
The most common (incidence greater than or equal to 30%) adverse reactions observed with Torisel are: rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence greater than or equal to 30%) are anemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.
Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of Torisel. If alternatives cannot be used, dose modifications of Torisel are recommended.
Please see TORISEL full prescribing information at http://www.wyeth.com.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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Wyeth Pharmaceuticals
CONTACT: Media, Candace Steele of Wyeth Pharmaceuticals, +1-484-865-5428,or Douglas Petkus, +1-973-660-5218, or Investors, Justin Victoria,+1-973-660-5340, both of Wyeth
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