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More than 400 patients participated in this study, all of whom had disease that had progressed with currently available targeted therapies sunitinib and/or sorafenib. Patients were randomized to receive everolimus or placebo. After six months, 26 percent of patients in the everolimus group had disease that had not progressed, compared to only 2 percent of the placebo group. The average difference in progression free survival was four months for everolimus, compared to 1.9 months for the placebo group.

In February, 2008, an independent monitoring committee stopped the Phase III trial after interim results were positive and allowed researchers to offer everolimus to the patients receiving placebo.

"For almost 20 years, we made no headway in the management of advanced kidney cancer," notes Dr. Motzer. "Recently, the identification of several new angiogenesis- targeted agents has provided us with new treatment options and an improved outlook for patients with advanced kidney cancer. Based on the results of this trial, everolimus could become another tool in our armamentarium and, in the future, kidney cancer is likely to be managed as a chronic disease with these types of treatment advances."

Everolimus was well tolerated by patients and the most common side effects were mouth ulcers, anemia, skin rash and weakness.

In addition to Dr. Motzer, contributors to the study included researchers from Institut Gustave Roussy in Villejuif, France; Georges Pompidou European Hospital in Paris, France; San Matteo University Hospital in Pavia, Italy; US Oncology, Baylor-Sammons Cancer Center/TOPA in Dallas, Texas; Azienda Ospedaliera in Perugia, Italy; Novartis Pharmaceuticals in Florham Park, New Jersey; and Hôpital Saint André CHU in Bordeaux, France. The study was funded by grants from Novartis Pharmaceuticals.