Pfizer reports final results from randomized Phase 3 trial of Sutent

Pfizer Inc. today announced final results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic neuroendocrine tumors, a type of cancer which originates in the hormone-producing area of the pancreas. Sunitinib more than doubled the time patients with pancreatic neuroendocrine tumors lived without disease progression compared with patients treated with placebo, according to study findings that will be presented tomorrow at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in Orlando, Florida.

“This trial advances our understanding of the use of novel targeted therapies in a patient population with limited treatment options”

An independent Data Monitoring Committee (DMC) recommended halting the trial in February 2009 because sunitinib showed significant benefit and the primary endpoint was met.

"This trial advances our understanding of the use of novel targeted therapies in a patient population with limited treatment options," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. "We are pleased to be working toward filling an unmet patient need, as we did with Sutent four years ago in patients with kidney cancer and gastrointestinal stromal tumors."

The Phase 3 study findings served as the basis for the recent filings of supplemental applications for sunitinib in the treatment of pancreatic neuroendocrine tumors with the regulatory authorities in the US, Europe and Canada.

Phase 3 Trial Results

This international, Phase 3 trial compared sunitinib with placebo in patients with progressive, well-differentiated, malignant pancreatic neuroendocrine tumors. Patients were randomized to either the sunitinib>

Results showed that median progression-free survival (PFS) was 11.4 months in patients treated with sunitinib compared with 5.5 months in patients treated in the placebo arm (Hazard ratio 0.418, p<0.001). Sutent also prolonged overall survival, a secondary endpoint of the trial (Hazard ratio 0.409,>

“The magnitude of Sutent’s benefit in the pancreatic neuroendocrine tumor patient population was an encouraging finding,” said Dr. Eric Raymond, professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, and lead investigator on this sunitinib Phase 3 study. “These findings offer hope to a patient population for whom there are limited treatment options.”

Adverse events were similar to those observed in other sunitinib studies. The most commonly reported grade 3-4 adverse events in the sunitinib arm were neutropenia (12 percent), hypertension (9.6 percent), hand-foot syndrome (6 percent), leukopenia (6 percent) abdominal pain (4.8 percent), diarrhea (4.8 percent), asthenia (4.8 percent), fatigue (4.8 percent) and hypoglycemia (4.8 percent). Grade 5 cardiac failure was experienced by 1.2 percent of the patients in the sunitinib arm.