MADISON, N.J., June 4 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that preliminary data from an interim analysis of its ongoing phase 3 clinical trial of investigational temsirolimus (CCI-779) for the treatment of advanced renal cell carcinoma (RCC) showed that single-agent therapy with temsirolimus significantly increased overall survival as a first-line treatment of patients with advanced disease and poor risk features compared to interferon-alpha, a treatment for advanced RCC. In the trial, patients who were treated with temsirolimus alone experienced a 3.6-month, or 49 percent, increase in median overall survival time compared with patients treated with interferon-alpha alone (10.9 months vs. 7.3 months, p=0.0069). These data were presented during a late-breaking plenary session at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia.
Temsirolimus is a specific inhibitor of mTOR (mammalian target of rapamycin), a signaling protein that regulates cell growth and angiogenesis.
"Advanced renal cell carcinoma is a particularly difficult form of cancer to treat, and despite recent advances, patients still have few treatment options," says Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, PA. "The ability to improve survival for these patients with advanced renal cell carcinoma and poor-risk features by three and a half months is quite an achievement, and shows that mTOR inhibition may be a viable approach in this disease area."
This open-label, randomized, phase 3 trial compared temsirolimus alone or a combination of temsirolimus plus interferon-alpha to interferon-alpha alone as first-line therapy. Participants included 626 patients with advanced RCC and poor risk features who had received no prior systemic therapy. The primary endpoint of the study was overall survival.
In this interim analysis, the median survival of patients who were treated with investigational temsirolimus alone was 49 percent longer compared with patients who were treated with interferon-alpha alone. The median overall survival time among patients in the combination group was 15 percent longer than in the interferon-alpha group, though this result was not statistically significant.
The most significant adverse events reported in arm 1 (interferon-alpha alone), arm 2 (temsirolimus alone) and arm 3 (temsirolimus in combination with interferon-alpha) included asthenia (27 percent, 12 percent and 30 percent, respectively), anemia (24 percent, 21 percent and 39 percent, respectively) and dyspnea (8 percent, 9 percent and 11 percent, respectively). Of the 626 patients enrolled in the study, 442 deaths occurred at the time of this interim analysis. Patients remain on treatment and continue to be followed for survival in this ongoing study.
In August 2004, the U.S. Food and Drug Administration (FDA) granted fast track designation for temsirolimus, an investigational mTOR kinase inhibitor, for first-line treatment for patients with advanced RCC and poor risk features. In December 2004, the FDA granted orphan drug designation to investigational temsirolimus for the treatment of advanced RCC.
About Renal Cell Carcinoma
Renal cell carcinoma accounts for about 85 percent of all renal cancers. Globally, there were expected to be 74,000 cases in the world's seven major pharmaceutical markets in 2005, 36,000 occurring in the United States alone, according to Datamonitor. The incidence of the disease is highest among people between the ages of 50 and 70, and it affects nearly twice as many men as women.
Approximately 25 percent of patients with RCC are initially diagnosed with advanced disease, including locally invasive or metastatic RCC. Patients with the most advanced form of the disease have a five-year survival rate of 20 percent.
About Temsirolimus
Temsirolimus is an investigational drug that is designed to specifically inhibit mTOR (mammalian target of rapamycin) kinase, a protein that regulates tumor growth and cell survival. Wyeth continues to study temsirolimus in a phase 3 trial of patients with mantle cell lymphoma and is planning phase 1 combination studies in renal cell cancer patients. Other early oncology trials with temsirolimus are being conducted through a cooperative research and development agreement with the National Cancer Institute in several other tumor types. Anti-tumor activity with temsirolimus has been previously reported in phase 1 and phase 2 studies.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, 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.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
