Pfizer's Sutent effective vs rare pancreatic cancer

Thu Jun 25, 2009 8:00am EDT
 
[-] Text [+]
 * Progression-free survival 11.1 months vs 5.5 months
 * Result highly statistically significant
 * Study halted early due to Sutent benefit
 By Bill Berkrot
 NEW YORK, June 25 (Reuters) - Pfizer Inc's (PFE.N) Sutent
delayed the worsening of the type of pancreatic cancer that
afflicted Apple Inc (AAPL.O) Chief Executive Steve Jobs by more
than five months longer than a placebo, according to data from
a clinical trial.
 The study, which involved 154 patients with advanced
pancreatic islet cell tumors, was stopped early by independent
safety monitors because Sutent had demonstrated significant
benefit and had met the primary goal of the trial.
 Median progression-free survival -- the time it took for
the disease to worsen in half the patients -- was 11.1 months
for those who took Sutent compared with 5.5 months in the
placebo group, according to data presented on Thursday at the
World Congress on Gastrointestinal Cancer meeting in
Barcelona.
 The result was deemed to be highly statistically
significant.
 "In this study, Sutent demonstrated an impressive
improvement in progression-free survival for patients with
pancreatic islet cell tumors," Dr. Eric Raymond, lead
investigator of the Phase III trial, said in a statement.
 "This is encouraging news for patients, especially given
that there are limited treatment options for this type of
advanced cancer," Raymond said.
 Apple's Jobs underwent surgery for the disease in 2004. He
recently had a liver transplant, but it was not clear if that
was related to the pancreatic cancer.
 Sutent, known chemically as sunitinib, is currently
approved to treat advanced kidney cancer and gastrointestinal
stromal tumor, a cancer of the digestive system.
 Pancreatic islet cell tumors, also known as neuroendocrine
tumors, are a rare form of the disease affecting two to four
people per million worldwide annually, or about 5 percent of
pancreatic cancer cases, according to the National Cancer
Institute. An expanded approval to include the disease would
likely not add significantly to Sutent revenue.
 Patients in the study had malignant tumors that had
progressed in the last 12 months. All received best supportive
care plus either Sutent or a placebo.
 The most common adverse events in patients who received
Sutent included low white blood cells, high blood pressure,
abdominal pain, diarrhea, low blood sugar and swelling of the
hands and feet. These were similar to side effects seen in
previous Sutent studies, Pfizer said.
 Mace Rothenberg, head of clinical development and medical
affairs for Pfizer's oncology business unit, called the study's
results welcome news, "as there is currently no standard of
care for patients with pancreatic islet cell tumors who
progress on prior therapy."
 Full analysis of the data is ongoing, Pfizer said.
 (Reporting by Bill Berkrot, editing by Matthew Lewis)


 

Featured Broker sponsored link