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Wyeth kidney cancer drug shows promise in trial

Posted on: Sunday, 4 June 2006, 06:06 CDT

By Toni Clarke

ATLANTA (Reuters) - Wyeth said on Sunday that interim results of a late-stage trial of its experimental kidney cancer drug significantly increased survival in patients compared to standard therapy.

Patients with advanced kidney cancer who took the drug, temsirolimus, had a median survival time of 10.9 months, compared to a survival time of 7.3 months for patients who took the standard therapy.

Data from the late-stage, or Phase III, trial were presented at the annual meeting of the American Society of Clinical Oncology in Atlanta.

Temsirolimus blocks a protein known as mTOR, which is a signaling protein that regulates cell growth and the growth of blood vessels.

There are about 39,000 cases of kidney cancer diagnosed in the United States each year, according to the American Cancer Society. Patients with the most advanced form of the disease have a five-year survival rate of 20 percent.

All patients in the study had advanced kidney cancer that had spread. One group got temsirolimus alone, one group was given standard therapy alone and one group received temsirolimus and standard therapy.

The median survival for the temsirolimus alone group was 10.9 months; for the combination group it was 8.4 months and for the standard therapy group it was 7.3 months.

"Until just a few years ago there were no promising drugs for kidney cancer," said Dr. Gary Hudes, director of the genitourinary malignancy program at Fox Chase Cancer Center and the study's lead author.

The drug was tested in patients whose cancer was so advanced that they would not qualify for most other clinical trials.

Recently, U.S. regulators approved Pfizer Inc.'s kidney cancer drug Sutent and a drug called Nexavar from Bayer AG and Onyx Pharmaceuticals.

"With both launches still in their infancy, it is still not certain how the treatment paradigm will ultimately be defined," said Phil Nadeau, an analyst at Cowen & Co., in a recent report.

Prior to the introduction of Sutent and Nexavar, the standard of care in metastatic renal cancer was high doses of several toxic drugs.

According to Hudes, the long-term goal for the emerging class of targeted agents for kidney cancer is to determine the optimal way to administer them, either in combination or sequentially.

Source: REUTERS

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