Promising Therapy For Pancreatic Cancer Patients
A new drug called MM-398 when given in combination with 5-flourouracil (5FU) and leucovorin produces significant overall survival rate in patients with advanced, previously treated pancreatic cancer, a new study has reported.
The clinical trial was conducted by researchers at the Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).
The NAPOLI-1 (NAnoliPOsomaL Irinotecan) Phase 3 study, considered as a final confirmation of drug's safety and effectiveness, was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine. It is also considered as the standard-of-care therapy for such patients.
The study evaluated 417 patients enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia.
"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, MD, FACP, global principal investigator of the NAPOLI-1 study, Chief Scientific Officer for Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief and Distinguished Professor at TGen, in the press release. "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."
The combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone, press release added.
Each year in the United States, more than 45,000 people are diagnosed with pancreatic cancer, out of which more than 39,000 patients die, making it the fourth leading cause of cancer death. According to reports, only about 1 in 4 patients survive more than one year after diagnosis while only 6 percent survive after more than five years.
Researchers will present their findings at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer being held June 25-28 in Barcelona, Spain.