- Merrimack Pharmaceuticals (NASDAQ:MACK) is ahead 8% premarket on higher-than-average volume in response to its announcement of final results from the Phase 3 NAPOLI-1 study assessing ONIVYDE (irinotecan liposome injection), in combination with standard-of-care fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic ductal adenocarcinoma following gemcitabine-based therapy. The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
- Overall survival favored the combination over standard-of-care, 6.2 months versus 4.2 months (p=0.039) with a 25% lower risk of death or cancer progression (hazard ratio = 0.75). One in four patients in the ONIVYDE cohort survived at least one year. The disease control rate (responders + those with stable disease) also favored the ONIVYDE combo regimen, 52% vs. 24%.
- The product was approved in the U.S. and Taiwan in October 2015. It was given a thumbs up by the Advisory Committee in Europe in July.
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ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
- Previously: Merrimack posts increased survival rate in Oivyde trial (Jan. 19)