Oncology: Renal cell cancer slowed by Novartis' RAD001

Nearly two-thirds of renal cell cancer patients taking Novartis AG's RAD001 (everolimus) had progression of their disease delayed by a year, a significantly better result than in those taking placebo. Everolimus may offer potential new treatment option for patients with advanced kidney cancer who have failed standard therapies. The study assessed patients whose cancer had worsened despite receiving approved treatments for renal cancer, such as Bayer AG's Nexavar or Pfizer Inc's Sutent, or both.

Amazingly, the disease did not progress for one year in 65 percent of patients taking the once-daily RAD001 tablet, compared to 37 percent in those taking placebo, according to detailed results from a late-stage trial, which was stopped early because it met its main target.

The drug works by blocking a protein known as mTOR and disrupts the growth, division and metabolism of cancer cells.

Full results of the trial are due to be presented in an oral session at ASCO later this month (Abstract #LBA5026: Saturday, May 31, 2008; 4:30 PM-4:45 PM CDT).

There were 410 patients in the trial, 272 taking RAD001 and 138 placebo. Novartis announced it intends to file the drug for regulatory approval later this year.