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>