Pfizer Stops Pancreatic Trial after Strong Results

Pfizer’s Phase III trial of Sutent has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, or pancreatic neuroendocrine tumors. An independent Data Monitoring Committee (DMC) concluded that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors and recommended stopping the trial.

“We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors — a rare cancer with limited treatment options,” said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit. “These and previously reported Phase II data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors.”

Pfizer notified clinical trial investigators and regulatory agencies of the DMC recommendations. All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent. Full data from the trial is being analyzed and details will be presented at an upcoming meeting.

Pancreatic islet cell tumors are rare tumors of the endocrine pancreas with an incidence of 5-10 per million worldwide annually. Pancreatic islet cell tumors include insulinomas, glucagonomas and gastrinomas and current treatment options are limited. Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST).