Global drug company Pfizer Inc announced yesterday, 12 March, that a phase 3 clinical trial of its pancreatic cancer drug Sutent (sunitinib malate) stopped early because the drug showed significant benefits in patients.
Sutent is designed to treat patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.
It is an oral multi-kinase inhibitor (blocks the action of molecules that help the cancer to spread) and is already approved for the treatment of both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST). More than 38,000 patients with these diseases have been treated with the drug, both in clinical settings and in trials.
The independent Data Monitoring Committee (DMC) that was overseeing this trial recommended it stop after finding that the drug had shown greater progression-free survival compared to placebo (patients lived longer without the cancer spreading), and best supportive care in patients with pancreatic islet cell tumors, said Pfizer in a press statement. Once the trial data is fully analyzed, it will be presented at a scientific meeting, they added.
Pancreatic islet cell tumors are rare, with an incidence of 5 to 10 per million worldwide annually. Such tumors include insulinomas, glucagonomas and gastrinomas, and current treatment options are limited.
The participating centers have now been informed of the decision, so all the patients taking part in the trial can choose to continue on Sutent or switch from placebo to the drug.
Dr Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit told the press:
“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 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors,” he added.
The phase 3 trial followed the successful completion of the phase 2 trial which was reported in the July 2008 issue of the Journal of Clinical Oncology.
Pfizer reported that this is the second phase 3 trial of Sutent that has stopped early on the recommendation of the trial’s DMC because it has shown benefits to patients. In January 2005, when Sutent was being trialled for use with GIST patients, the trial was unblinded early when results showed the drug delayed tumor progression compared to placebo.
The company is also looking to test the drug in phase 3 trials for the treatment of other solid tumors, including advanced breast cancer, advanced non-small cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma and advanced hormone-refractory prostate cancer.
According to the Associated Press, the news sent Pfizer shares up by nearly 10 per cent on Thursday. Sutent is already the New-York based company’s best-selling cancer drug, earning 847 million dollars in sales in 2008, of which 254 million was in the US, said the AP announcement.
Sources: Pfizer, Associated Press.
Written by: Catharine Paddock, PhD