* 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)