Singapore: Investigational agent, tivozanib, has demonstrated statistically significant and clinically meaningful PFS superiority versus approved targeted agent sorafenib in advanced Renal Cell Carcinoma (RCC). Data from TIVO-1 is the first superiority pivotal study in first-line advanced RCC.

The drug is being developed by AVEO Oncology, a cancer therapeutics company, along with Tokyo-based Astellas Pharma. In a press statement, the two companies said detailed data from TIVO-1 will be presented on June 2, 2012, at the 2012 Annual Meeting of the American Society of Clinical Oncology.

"TIVO-1 is novel in that this phase III clinical study used an approved targeted comparator drug to evaluate first-line RCC treatment," said Dr Motzer. "Patients in the study who had no prior treatment for advanced kidney cancer and who were given tivozanib met the primary PFS endpoint and tolerated the drug well."

A total of 517 patients were randomized to tivozanib or sorafenib. The performance status and other prognostic indicators of patients enrolled in this study were found to be consistent with other pivotal trials in first line advanced RCC. "Despite recent advances in the treatment of kidney cancer, patients are in need of new options which are effective and well-tolerated," said Daniel George, director, GU Medical Oncology and director, prostate clinic, Duke University. "The superior PFS and favorable tolerability demonstrated by tivozanib in TIVO-1 represents an important potential step forward for patients in the treatment of kidney cancer."

Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from RCC each year. It accounts for more than 90 percent of all kidney cancers. Currently available therapies provide less than one year of median PFS in treatment-naïve patients and are associated with significant toxicities.

Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a phase III clinical study in advanced renal cell carcinoma have been reported, and is being evaluated in other tumors.