From: Reuters
Published May 16, 2008 06:15 PM

Experimental Novartis drug slows kidney cancer

WASHINGTON (Reuters) - An experimental drug from Swiss drugmaker Novartis slowed the progression of kidney cancer in patients whose tumors returned after initial chemotherapy, researchers reported on Friday.

The drug, called RAD-001 or everolimus, may provide an option for patients with a difficult-to-treat cancer, the researchers said in an initial release of data ahead of a meeting of the American Society of Clinical Oncology.

The international team studied more than 400 people with kidney cancer, giving RAD-001 to 272 of them and placebos to 138 patients.

After six months, tumors had not grown or spread in 26 percent of patients who got RAD-001, compared to 2 percent of the placebo group.


On average, patients who got RAD-001 enjoyed four months of so-called progression-free survival compared to just under two months for those who got the placebo.

Independent monitors who watch drug trials were so impressed by the results that they stopped the trial last February so everyone could get RAD-001.

"This study has given us a new and clearly useful tool for treating renal cell tumors, and everolimus is an important step forward in terms of disease management and quality of life for patients living with this disease," said Dr. Robert Motzer of Memorial Sloan-Kettering Cancer Center in New York, who led the study.

Full details will be presented on May 31 at the ASCO annual meeting. Novartis has said it intends to file for regulatory approval of the drug later this year.

Kidney cancer will be diagnosed in 54,390 people in the United States this year and will kill 13,010, the American Cancer Society projects.

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

The once-a-day pill is also being tested in other cancers including lymphoma and neuroendocrine tumors.

"For almost 20 years, we made no headway in the management of advanced kidney cancer," Motzer said in a statement.

"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."

(Reporting by Maggie Fox; Editing by Xavier Briand)

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