USA-based Merrimack Pharmaceuticals (Nasdaq: MACK) has announced positive results from a Phase III study of its new combination treatment in pancreatic cancer.
The NAPOLI-1 Phase III study was conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. It found that 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. The primary log-rank analysis of overall survival was statistically significant with a corresponding hazard ratio of 0.67. A statistically significant advantage for progression free survival was also observed in the combination arm.
Robert Mulroy, president and chief executive of Merrimack, said: “We are excited by the results of the NAPOLI-1 study because of the critical need to help patients with this devastating illness and are moving forward as quickly as possible to get MM-398 to patients. Given that there have only been a handful of successful Phase III trials in pancreatic cancer in the past 25 years, it is gratifying to have the first positive Phase III trial in the post-gemcitabine setting. The results reinforce our confidence in our entire nanoliposomal pipeline.”
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