Date: 2015-12-15
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: NewLink Genetics (USA - IO)
Product: algenpantucel-L
Action
mechanism: immunotherapy product/cell therapy. Algenpantucel-L is an allogenic pancreatic cancer vaccine. It is comprised of two human pancreatic ductal adenocarcinoma cell lines (HAPa-1 and HAPa-2) that have been genetically engineered to express ?(1,3)- galactosyl epitopes (?Gal) by using retroviral transfer of the murine ?GT gene.
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: PILLAR is a Phase 3, 1:1 randomized trial assessing overall survival for patients with borderline resectable or locally advanced unresectable pancreatic cancer treated with a regimen of FOLFIRINOX or gemcitabine/nab-paclitaxel in combination with algenpantucel-L cellular immunotherapy versus standard of care chemotherapy alone. The chemotherapy combination to be used in this study has been shown to improve survival in advanced pancreatic cancer and is being combined with an experimental pancreatic cancer immunotherapy that stimulates the immune system to recognize and attack the cancer. One goal of this study is to determine whether chemotherapy and immunotherapies can work cooperatively to increase anti-tumor effects to levels beyond what would be seen with either treatment alone. In this experimental study, all patients are given a strong combination of anti-tumor chemotherapies while some patients are also given injections of an immunotherapy drug consisting of two types of pancreatic cancer cells that we have modified to make them more easily recognized and attacked by the immune system. (NCT01836432)
Latest
news: * On December 15, 2015, NewLink Genetics announced the completion of enrollment in the Phase 3 PILLAR (Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable cancer) clinical trial of algenpantucel-L for patients with borderline resectable or locally advanced unresectable pancreatic cancer. Total enrollment in the study exceeded 300 patients.
