Pancreatic Drug Trial Halted on Promising Results

Sutent showed greater survival rates, Pfizer says

THURSDAY, March 12, 2009 (HealthDay News) -- Drug maker Pfizer Inc. said Thursday that a late-stage clinical trial of its cancer drug Sutent has been stopped early, because it showed significant benefit for patients with a rare form of pancreatic cancer.

The phase 3 trial included patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, the company said in a news release.

The trial results prompted an independent Data Monitoring Committee to recommended halting the test after concluding that Sutent (sunitinib malate) showed greater "progression-free survival" than a placebo, the company said.

"These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors," Dr. Mace Rothenberg, Pfizer's senior vice president of medical development and clinical affairs, said in the release.

The company said all participants in the trial will have the choice of continuing treatment with Sutent or switching from a placebo to the drug. Complete data from the trial is being "analyzed and more details will be presented at an upcoming scientific meeting," the news release said. Details on the duration of survival benefit for those using Sutent have not yet been released.

Pancreatic islet cell tumors are rare malignancies of the pancreas, with an incidence of five million to 10 per million worldwide annually, Pfizer said.

Steve Jobs, chief executive officer of Apple Inc., said he was diagnosed in 2004 with that form of the disease, Bloomberg News reported.

Sutent has already been approved by the U.S. Food and Drug Administration for the treatment of certain kidney and stomach cancers. More than 38,000 patients worldwide have been treated with the drug in the clinical setting and trials, Pfizer said.

Sutent has also been the subject of controversy, after recent studies suggested it might boost patients' blood pressure and increase their risk for heart failure. In December, Pfizer issued a statement saying that these cardiovascular risks "were medically manageable in most patients and underscore the importance of having a collaborative team of health-care professionals working together to appropriately manage patients who have limited available options" in treating their cancer.

More information

For more on pancreatic cancer, visit the American Cancer Society.

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