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
To compare the efficacy and safety of algenpantucel-L [HyperAcute-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 adv...
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| Veröffentlicht in: | Annals of surgery Jg. 275; H. 1; S. 45 |
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01.01.2022
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| Abstract | To compare the efficacy and safety of algenpantucel-L [HyperAcute-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).
To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.
A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.
Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).
Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.
ClinicalTrials.gov Identifier: NCT01836432. |
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| AbstractList | To compare the efficacy and safety of algenpantucel-L [HyperAcute-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).
To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.
A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.
Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).
Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.
ClinicalTrials.gov Identifier: NCT01836432. To compare the efficacy and safety of algenpantucel-L [HyperAcute-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).OBJECTIVESTo compare the efficacy and safety of algenpantucel-L [HyperAcute-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).To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.SUMMARY BACKGROUND DATATo date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.METHODSA multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).RESULTSBetween May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.CONCLUSIONSAlgenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.ClinicalTrials.gov Identifier: NCT01836432.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT01836432. |
| Author | Hatoum, Hassan Elquza, Emad Rossi, Gabriela Seng, John Al-Rajabi, Raed Coveler, Andrew L Lavu, Harish LoConte, Noelle George, Thomas J Yeo, Charles J Leiby, Benjamin Banks, Joshua Vaccaro, Gina Kennedy, Eugene Musher, Benjamin Hewitt, Daniel Brock Vahanian, Nicholas Brenner, Warren Nissen, Nicholas Link, Charles Balducci, Lodovico |
| Author_xml | – sequence: 1 givenname: Daniel Brock surname: Hewitt fullname: Hewitt, Daniel Brock organization: Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania – sequence: 2 givenname: Nicholas surname: Nissen fullname: Nissen, Nicholas organization: Cedars Sinai Medical Center, Los Angeles, California – sequence: 3 givenname: Hassan surname: Hatoum fullname: Hatoum, Hassan organization: University of Oklahoma, Oklahoma City, Oklahoma – sequence: 4 givenname: Benjamin surname: Musher fullname: Musher, Benjamin organization: Baylor College of Medicine, Houston, Texas – sequence: 5 givenname: John surname: Seng fullname: Seng, John organization: Virginia Piper Cancer Institute, Minneapolis, Minnesota – sequence: 6 givenname: Andrew L surname: Coveler fullname: Coveler, Andrew L organization: University of Washington-Seattle Cancer Care, Seattle, Washington – sequence: 7 givenname: Raed surname: Al-Rajabi fullname: Al-Rajabi, Raed organization: University of Kansas Cancer Center, Westwood, Kansas – sequence: 8 givenname: Charles J surname: Yeo fullname: Yeo, Charles J organization: Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania – sequence: 9 givenname: Benjamin surname: Leiby fullname: Leiby, Benjamin organization: Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania – sequence: 10 givenname: Joshua surname: Banks fullname: Banks, Joshua organization: Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania – sequence: 11 givenname: Lodovico surname: Balducci fullname: Balducci, Lodovico organization: H. Lee Moffitt Cancer Center, Tampa, Florida – sequence: 12 givenname: Gina surname: Vaccaro fullname: Vaccaro, Gina organization: Oregon Health and Science University, Portland, Oregon – sequence: 13 givenname: Noelle surname: LoConte fullname: LoConte, Noelle organization: University of Wisconsin, Madison, Wisconsin – sequence: 14 givenname: Thomas J surname: George fullname: George, Thomas J organization: University of Florida, Gainesville, Florida – sequence: 15 givenname: Warren surname: Brenner fullname: Brenner, Warren organization: Boca Raton Hospital, Boca Raton, Florida – sequence: 16 givenname: Emad surname: Elquza fullname: Elquza, Emad organization: University of California at Irvine, Irvine, California – sequence: 17 givenname: Nicholas surname: Vahanian fullname: Vahanian, Nicholas organization: NewLink Genetics Corporation, Ames, Iowa – sequence: 18 givenname: Gabriela surname: Rossi fullname: Rossi, Gabriela organization: NewLink Genetics Corporation, Ames, Iowa – sequence: 19 givenname: Eugene surname: Kennedy fullname: Kennedy, Eugene organization: Lumos Pharma Inc, Ames, Iowa – sequence: 20 givenname: Charles surname: Link fullname: Link, Charles organization: NewLink Genetics Corporation, Ames, Iowa – sequence: 21 givenname: Harish surname: Lavu fullname: Lavu, Harish organization: Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania |
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| References | 35284521 - Hepatobiliary Surg Nutr. 2022 Feb;11(1):115-118 34430537 - Hepatobiliary Surg Nutr. 2021 Aug;10(4):534-537 |
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| Title | 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 |
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