2020
DOI: 10.1097/sla.0000000000004669
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A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

Abstract: Objectives: To compare the efficacy and safety of algenpantucel-L [Hyper-Acute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). Summary Background Data: To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable

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Cited by 58 publications
(49 citation statements)
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“…The addition of algenpantucel-L improved both disease-free survival (DFS) and OS (after a median follow-up of 21 months, the 12-month DFS rate was 62%, and the 12-month OS rate was 86%). However, the phase III trial did not confirm the previous findings, showing similar outcomes regardless of the addition of algenpantucel-L to standard treatment [ 123 ].…”
Section: Immunotherapymentioning
confidence: 62%
“…The addition of algenpantucel-L improved both disease-free survival (DFS) and OS (after a median follow-up of 21 months, the 12-month DFS rate was 62%, and the 12-month OS rate was 86%). However, the phase III trial did not confirm the previous findings, showing similar outcomes regardless of the addition of algenpantucel-L to standard treatment [ 123 ].…”
Section: Immunotherapymentioning
confidence: 62%
“…Resected patients had an overall survival of 28.7 months compared to 12.6 months in unresected patients. Vaccination did not improve survival in either of the subgroups (6).…”
mentioning
confidence: 77%
“…HepatoBiliary Surg Nutr 2021 | https://dx.doi.org/10.21037/hbsn-21-238 borderline resectable or unresectable, locally advanced pancreatic cancer (6). Algenpantucel-L is an intradermal vaccine made of two irradiated pancreatic cancer cell lines genetically modified to express murine α1,3galactosyltransferase.…”
mentioning
confidence: 99%
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“…The mechanism of action was based on the epitope spreading, which amplified the host immune response, leading to the death of PDAC cells by activation of antibody-dependent cell-mediated cytotoxicity. Unfortunately, the trial did not show any benefit in survival by adding algenpantucel-L to the chemotherapy if compared with the control arm (median overall survival 14.3 vs. 14.9 months, respectively; HR: 1.02, p = 0.98) [93].…”
Section: Immunotherapy In the Neo-adjuvant Setting For Pdacmentioning
confidence: 95%