Pfizer Reports Positive Results from Clinical Trials of Oncology Drug Sutent

Pharma major Pfizer Thursday reported that its oncology drug Sutent had been found successful in slowing progression of advanced pancreatic cancer.

An independent data monitoring committee recommended early stoppage of a Phase III clinical trial for Sutent, Pfizer said, after patients who had advanced pancreatic islet cell tumors showed greater progression-free survival rates.

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The trial began in 2007 and was designed to test Sutent versus a fake drug, or placebo, in about 340 people with advanced pancreatic islet cell tumors, with expected completion by March 2011. The primary measure of effectiveness was progression-free survival, or time until death or disease progression.

The data-monitoring committee recommended stopping the trial early after it concluded Sutent improved progression-free survival versus placebo. Those on placebo also received "best supportive care," which sometimes includes medications to alleviate symptoms.

Sutent is already approved to treat renal and gastrointestinal cancer. Pancreatic cancer is an extremely deadly form of the disease, with few treatment options available.

Pfizer plans to unveil details from the study at an upcoming scientific meeting. The drugmaker has been testing Sutent, also called sunitinib, in the treatment of cancers of the lung, colon, liver and prostate.

The finding is another positive for Sutent, which last month was backed for use in kidney cancer by the U.K. agency that decides which treatments are made available in the publicly funded health-care system in England and Wales, reversing an earlier recommendation. The agency still rejected several other companies' drugs for kidney cancer. Sutent is approved in the U.S. to treat kidney cancer and a digestive-tract cancer.

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This is the second Phase 3 trial of Sutent that Pfizer has stopped early on the recommendation of an independent committee due to benefit, the company said. In January 2005, it called a halt to a stomach-cancer trial after analysis showed tumors progressed significantly slower with the drug.

A secondary goal of the Suten trial was to measure whether Sutent actually extended lives, but it's unclear whether the trial's early halt will make that impossible to measure, Peter Loftus reported for Dow Jones Newswires

Sutent had sales of $847 million in 2008.

The latest Sutent trial is a welcome success for Pfizer's research efforts, which have been marked by disappointments in recent years. In just the last six weeks, Pfizer has ended a study of an experimental drug for a more common form of pancreatic cancer because it didn't work, and discontinued studies of treatments for fibromyalgia and anxiety because they weren't much better than existing drugs.

But the new Sutent study probably won't make a big difference to Pfizer's financial performance because the population of patients with this form of pancreatic cancer is relatively small, with an estimated incidence of five to 10 cases per million people worldwide annually.

Pfizer rival Novartis AG (NVS) is studying a drug known as everolimus in people with pancreatic islet cell tumors.
Source-Medindia
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