A clinical trial conducted by researchers at the Virginia G. Piper Cancer Center Clinical Trials showed that a new drug called MM-398 has produced a significant overall survival rate in patients with advanced, previously-treated pancreatic cancer.
The clinical trials are possible through a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute, according to a press release.
The NAPOLI-1 Phase 3 study — a final confirmation of a drug’s safety and effectiveness — was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine, which has been the standard-of-care therapy for such patients, the release states.
The study, sponsored by Merrimack Pharmaceuticals, evaluated 417 patients enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia.
Merrimack expects to submit a New Drug Application this year to the U.S. Food and Drug Administration (FDA) for the MM-398 combination regimen, the release states.
“This demonstration of a survival benefit from the MM-398 plus 5-FU and leucovorin combination is particularly important given that we have very few treatment options for patients in this tough clinical setting,” said Dr. Daniel D. Von Hoff, global principal investigator of the NAPOLI-1 study.
“The results of the NAPOLI-1 study are important because of the critical need to help patients with this devastating illness and move forward towards FDA approval.”
Each year in the U.S., nearly 46,000 people are diagnosed with pancreatic cancer, and more than 39,000 patients die, making it the fourth leading cause of cancer death, according to the release.
Only about 1 in 4 patients survive more than one year after diagnosis, and only 6 percent survivor more than five years.
This study will be presented at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer being held June 25-28 in Barcelona, Spain, the release states.
Comments are closed.