Newlink Genetics Corp. said Friday its phase III IMPRESS trial of algenpantucel-L in patients with surgically resected pancreatic cancer will continue without modification on the recommendation of the independent data safety monitoring board (DSMB) following the first of two planned interim analyses.
The DSMB’s initial review of IMPRESS (Immunotherapy for Pancreatic Resectable Cancer Survival Study) was scheduled to occur following 222 patient events in the trial, which completed enrollment of 722 patients in September 2013. A second interim analysis is planned at 333 patient events and, if needed, a final analysis at 444 events.
The phase III of lead candidate algenpantucel-L, also known as HyperAcute pancreas, is being conducted under a special protocol assessment (SPA) with the FDA. The study – the largest pivotal immunotherapy trial ever conducted in the U.S. in resected pancreatic cancer, according to Newlink chairman and CEO Charles