May 16, 2008 / 1:02 AM / 11 years ago

Study shows RAD001 froze kidney cancer for a year

WASHINGTON (Reuters) - Nearly two-thirds of kidney cancer patients taking Novartis AG’s RAD001 had progression of their disease delayed by a year, a significantly better result than in those taking placebo, investigators said.

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 is also known as everolimus and works by blocking a protein known as mTOR and hence disrupting the growth, division and metabolism of cancer cells.

“RAD001 resulted in a statistically and clinically significant improvement in progression free survival over placebo with a favorable safety profile in patients with metastatic renal cell carcinoma,” the investigators wrote.

The investigators’ written summary was presented ahead of an American Society of Clinical Oncology (ASCO) conference. Full results of the trial are due to be presented at ASCO, which starts May 30.

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

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.

Reporting by Maggie Fox; editing by Elaine Hardcastle

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