Randomized dose-finding clinical trial of oncolytic immunotherapeutic vaccinia JX-594 in liver cancer

Oncolytic viruses are under development for tumor treatment. David Kirn and colleagues now report their results of a randomized phase 2 dose-finding trial of JX-594, an oncolytic immunotherapeutic vaccinia virus, in patients with advanced hepatocellular carcinoma. The study shows that high-dose JX-5...

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Published inNature medicine Vol. 19; no. 3; pp. 329 - 336
Main Authors Heo, Jeong, Reid, Tony, Ruo, Leyo, Breitbach, Caroline J, Rose, Steven, Bloomston, Mark, Cho, Mong, Lim, Ho Yeong, Chung, Hyun Cheol, Kim, Chang Won, Burke, James, Lencioni, Riccardo, Hickman, Theresa, Moon, Anne, Lee, Yeon Sook, Kim, Mi Kyeong, Daneshmand, Manijeh, Dubois, Kara, Longpre, Lara, Ngo, Minhtran, Rooney, Cliona, Bell, John C, Rhee, Byung-Geon, Patt, Richard, Hwang, Tae-Ho, Kirn, David H
Format Journal Article
LanguageEnglish
Published New York Nature Publishing Group US 01.03.2013
Nature Publishing Group
Subjects
631/67/1059/2325
631/67/1504/1610
692/308/153
692/308/2779/109/1942
692/308/575
692/700/565/1331
Aged
Antitumor activity
Biomedicine
Cancer Research
Carcinoma, Hepatocellular - immunology
Carcinoma, Hepatocellular - mortality
Carcinoma, Hepatocellular - therapy
Care and treatment
Chemotherapy
Clinical trials
Colony-stimulating factor
Disease control
Dosage
Dose-Response Relationship, Immunologic
Female
Genomes
Granulocyte-macrophage colony stimulating factor
Granulocyte-Macrophage Colony-Stimulating Factor - biosynthesis
Granulocyte-Macrophage Colony-Stimulating Factor - immunology
Granulocyte-Macrophage Colony-Stimulating Factor - metabolism
Health aspects
Hepatocellular carcinoma
Humans
Immunity
Immunotherapy
Infectious Diseases
Liver cancer
Liver Neoplasms - immunology
Liver Neoplasms - mortality
Liver Neoplasms - therapy
Male
Metabolic Diseases
Middle Aged
Molecular Medicine
Neurosciences
Oncolysis
Oncolytic Virotherapy
Oncolytic Viruses - metabolism
Pharmacology
Prevention
Solid tumors
Survival
Survival Rate
Tumors
Vaccinia virus
Vaccinia virus - genetics
Vaccinia virus - physiology
Viral vaccines
Virus Replication
Viruses
United States
Online AccessGet full text
ISSN1078-8956
1546-170X
1546-170X
DOI10.1038/nm.3089

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Abstract Oncolytic viruses are under development for tumor treatment. David Kirn and colleagues now report their results of a randomized phase 2 dose-finding trial of JX-594, an oncolytic immunotherapeutic vaccinia virus, in patients with advanced hepatocellular carcinoma. The study shows that high-dose JX-594 was associated with significantly improved overall survival and induced radiographic responses and antitumor immunity. Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial ( n = 30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P = 0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
AbstractList Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial (n = 30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P = 0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial (n=30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P=0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial (n=30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P=0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
Oncolytic viruses are under development for tumor treatment. David Kirn and colleagues now report their results of a randomized phase 2 dose-finding trial of JX-594, an oncolytic immunotherapeutic vaccinia virus, in patients with advanced hepatocellular carcinoma. The study shows that high-dose JX-594 was associated with significantly improved overall survival and induced radiographic responses and antitumor immunity.Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial (n = 30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P = 0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial ( n = 30). Radiologists infused low-or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P = 0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
Oncolytic viruses are under development for tumor treatment. David Kirn and colleagues now report their results of a randomized phase 2 dose-finding trial of JX-594, an oncolytic immunotherapeutic vaccinia virus, in patients with advanced hepatocellular carcinoma. The study shows that high-dose JX-594 was associated with significantly improved overall survival and induced radiographic responses and antitumor immunity. Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose on subject outcome is unclear. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized phase 2 dose-finding trial ( n = 30). Radiologists infused low- or high-dose JX-594 into liver tumors (days 1, 15 and 29); infusions resulted in acute detectable intravascular JX-594 genomes. Objective intrahepatic Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (15%) and Choi (62%) response rates and intrahepatic disease control (50%) were equivalent in injected and distant noninjected tumors at both doses. JX-594 replication and granulocyte-macrophage colony-stimulating factor (GM-CSF) expression preceded the induction of anticancer immunity. In contrast to tumor response rate and immune endpoints, subject survival duration was significantly related to dose (median survival of 14.1 months compared to 6.7 months on the high and low dose, respectively; hazard ratio 0.39; P = 0.020). JX-594 demonstrated oncolytic and immunotherapy MOA, tumor responses and dose-related survival in individuals with HCC.
Audience Academic
Author Ngo, Minhtran
Rose, Steven
Dubois, Kara
Lencioni, Riccardo
Cho, Mong
Lim, Ho Yeong
Daneshmand, Manijeh
Patt, Richard
Moon, Anne
Hickman, Theresa
Bell, John C
Rhee, Byung-Geon
Reid, Tony
Lee, Yeon Sook
Hwang, Tae-Ho
Kim, Chang Won
Bloomston, Mark
Kirn, David H
Ruo, Leyo
Rooney, Cliona
Chung, Hyun Cheol
Burke, James
Breitbach, Caroline J
Kim, Mi Kyeong
Longpre, Lara
Heo, Jeong
AuthorAffiliation 6 Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Ilwon-Dong, Gang Nam-Gu, Seoul, South Korea
15 Rad MD, Doylestown, Pennsylvania, USA
1 Department of Internal Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Seo-Gu, Busan, South Korea
10 Centre for Innovative Cancer Therapeutics, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
12 Baylor College of Medicine, Houston, Texas, USA
4 Jennerex Inc., San Francisco, California, USA
5 Department of Surgery, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA
8 Division of Diagnostic Imaging and Intervention, Pisa University School of Medicine, Lungarno Pacinotti, Pisa, Italy
13 Texas Children’s Hospital, Houston, Texas, USA
11 Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, Texas, USA
2 Moores Cancer Center, University of California San Diego (UCSD), La Jolla, California, USA
16 Department of Pharmacology, Pusa
AuthorAffiliation_xml – name: 16 Department of Pharmacology, Pusan National University, Busan, South Korea
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– name: 8 Division of Diagnostic Imaging and Intervention, Pisa University School of Medicine, Lungarno Pacinotti, Pisa, Italy
– name: 13 Texas Children’s Hospital, Houston, Texas, USA
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/23396206$$D View this record in MEDLINE/PubMed
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Department of Pharmacology, Pusan National University, Busan, South Korea
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Snippet Oncolytic viruses are under development for tumor treatment. David Kirn and colleagues now report their results of a randomized phase 2 dose-finding trial of...
Oncolytic viruses and active immunotherapeutics have complementary mechanisms of action (MOA) that are both self amplifying in tumors, yet the impact of dose...
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StartPage 329
SubjectTerms 631/67/1059/2325
631/67/1504/1610
692/308/153
692/308/2779/109/1942
692/308/575
692/700/565/1331
Aged
Antitumor activity
Biomedicine
Cancer Research
Carcinoma, Hepatocellular - immunology
Carcinoma, Hepatocellular - mortality
Carcinoma, Hepatocellular - therapy
Care and treatment
Chemotherapy
Clinical trials
Colony-stimulating factor
Disease control
Dosage
Dose-Response Relationship, Immunologic
Female
Genomes
Granulocyte-macrophage colony stimulating factor
Granulocyte-Macrophage Colony-Stimulating Factor - biosynthesis
Granulocyte-Macrophage Colony-Stimulating Factor - immunology
Granulocyte-Macrophage Colony-Stimulating Factor - metabolism
Health aspects
Hepatocellular carcinoma
Humans
Immunity
Immunotherapy
Infectious Diseases
Liver cancer
Liver Neoplasms - immunology
Liver Neoplasms - mortality
Liver Neoplasms - therapy
Male
Metabolic Diseases
Middle Aged
Molecular Medicine
Neurosciences
Oncolysis
Oncolytic Virotherapy
Oncolytic Viruses - metabolism
Pharmacology
Prevention
Solid tumors
Survival
Survival Rate
Tumors
Vaccinia virus
Vaccinia virus - genetics
Vaccinia virus - physiology
Viral vaccines
Virus Replication
Viruses
Title Randomized dose-finding clinical trial of oncolytic immunotherapeutic vaccinia JX-594 in liver cancer
URI https://link.springer.com/article/10.1038/nm.3089
https://www.ncbi.nlm.nih.gov/pubmed/23396206
https://www.proquest.com/docview/1314959442
https://www.proquest.com/docview/2695357054
https://www.proquest.com/docview/1315633377
https://www.proquest.com/docview/1328510556
https://pubmed.ncbi.nlm.nih.gov/PMC4268543
Volume 19
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