Pfizer reports positive Phase III pancreatic cancer study results, halts trial

Pfizer has stopped a Phase III clinical trial of Sutent early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.

An independent data monitoring committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors.

Pfizer has notified clinical trial investigators involved in the trial 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.

Sutent is currently approved for both advanced renal cell carcinoma and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase III clinical trials.

Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s oncology business unit, said: 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. 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.