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MM-398 shows promise in phase 3 trial for pancreatic cancer
A phase 3 clinical trial of a new drug called MM-398, given in combination with 5-fluorouracil and leucovorin, has demonstrated an increased survival rate for pancreatic cancer patients. The trial was sponsored by Merrimack Pharmaceuticals and conducted by scientists in Virginia G. Piper Cancer Center Clinical Trials, which is a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen). The trial results are due to be presented at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer being held June 25-28 in Barcelona, Spain.

Pancreatic cancer is usually diagnosed late as symptoms are not often noticed early on. This complicates treatment and contributes to the dismal prognosis with this form of cancer, with only a quarter of patients surviving beyond one year and 6% beyond 5 years. Once the cancer has spread, surgery is not usually a treatment option and the patient is given chemotherapy.

Phase 3 trials are carried out for final confirmation of a drug’s safety and efficacy. This trial, called the NAPOLI-1 (NAnoliPOsomaL Irinotecan) Phase 3 study, was conducted on 417 patients at over 100 sites in North America, South America, Europe, Asia and Australia. Combining MM-398 with 5-fluorouracil and leucovorin resulted in an overall survival of 6.1 months, which represents a 1.9 month improvement over 5-fluorouracil and leucovorin alone. Merrimack will be submitting a New Drug Application to the US Food and Drug Administration for the combined MM-398 treatment in pancreatic cancer.

Dr. Daniel D. Von Hoff, who is the global Principal Investigator for the NAPOLI-1 study concludes: "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."


Press release: TGen-Scottsdale Healthcare; available from: [Accessed 6 June 2014].
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