ARTICLE | Clinical News

Algenpantucel-L: Phase III ongoing

March 10, 2014 7:00 AM UTC

NewLink said an independent DMC found that the open-label, U.S. Phase III IMPRESS trial evaluating HyperAcute Pancreas algenpantucel-L for surgically resected pancreatic cancer did not meet the predefined statistical threshold to stop the trial early. The DSMC recommended continuing the trial based on a planned interim analysis following 222 patient deaths; a second interim analysis is scheduled when there are 333 patient deaths. If necessary, a final analysis is scheduled to occur following 444 patient deaths. The trial, which has an SPA from FDA, is evaluating gemcitabine or gemcitabine plus 5-fluorouracil (5-FU) with or without HyperAcute Pancreas in about 700 patients. ...