Addition of algenpantucel-L immunotherapy to standard of care (SOC) adjuvant therapy for pancreatic cancer.

4049 Background: Resected pancreatic cancer carries a one year survival rate of ~65%. Algenpantucel (HyperAcute-Pancreas, HAPa) exploits the hyperacute rejection mechanism of xenotransplantation by administering genetically modified, irradiated, allogeneic tumor cells expressing aGal moieties on their surface. We propose that addition of algenpantucel-L to SOC adjuvant therapy may improve survival for patients with resected pancreatic cancer. Methods: Open-label, dose-finding, Phase 2 study (16 sites) evaluating HAPa (100/300 M cells / dose) + SOC (RTOG-9704: Gemcitabine + 5-FU-XRT) for resected pancreatic cancer patients. Primary endpoint: 1-year disease-free survival (DFS). Secondary Endpoints: overall survival (OS), toxicity and immunologic analysis. Results: : 70 patients, median age 62 years, 47% female, 81% lymph node positive, median tumor size 3.2 cm, and 17% post-operative CA 19-9 ≥ 180 received SOC + HAPa. 1-year DFS of 63% and OS of 86% compares favorably to historical controls (~45%% and 65%, ...