Intratumoral injection of hemagglutinating virus of Japan-envelope vector yielded an antitumor effect for advanced melanoma: a phase I/IIa clinical study
Hemagglutinating virus of Japan (HVJ; Sendai virus) is an RNA virus that has cell fusion activity. HVJ-envelope (HVJ-E) is a UV-irradiated HVJ particle that loses viral replication and protein synthesis activity but retains cell fusion activity. We recently reported that HVJ-E has antitumor effects...
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| Veröffentlicht in: | Cancer Immunology, Immunotherapy Immunotherapy, 2020-06, Vol.69 (6), p.1131-1140 |
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| creator | Kiyohara, Eiji Tanemura, Atsushi Nishioka, Megumi Yamada, Mizuho Tanaka, Aya Yokomi, Akinori Saito, Atsuhiro Sakura, Kazuma Nakajima, Toshihiro Myoui, Akira Sakurai, Toshiharu Kawakami, Yutaka Kaneda, Yasufumi Katayama, Ichiro |
| description | Hemagglutinating virus of Japan (HVJ; Sendai virus) is an RNA virus that has cell fusion activity. HVJ-envelope (HVJ-E) is a UV-irradiated HVJ particle that loses viral replication and protein synthesis activity but retains cell fusion activity. We recently reported that HVJ-E has antitumor effects on several types of tumors. Here, we describe the results of a first-in-human phase I/IIa study in patients with advanced melanoma, receiving intratumoral administration of HVJ-E. The primary aim was to evaluate the safety and tolerability of HVJ-E, and the secondary aim was to examine the objective tumor response and antitumor immunity. Six patients with stage IIIC or IV progressive malignant melanoma with skin or lymph metastasis were enrolled. Patients were separated into two groups (
n
= 3 each) and received low and high doses of HVJ-E. Five of the six patients completed 4 weeks of follow-up evaluation; one patient discontinued treatment owing to progressive disease. Complete or partial responses were observed in 3 of 6 (50%) injected target lesions, 7 of 15 (47%) noninjected target lesions, and 10 of 21 (48%) target lesions. Induction of antitumor immunity was observed: activation of natural killer cells, a marked increase in interferon-γ levels in the peripheral blood, and infiltration of cytotoxic T cells into both injected and noninjected tumor lesions. Thus, intratumoral injection of HVJ-E in advanced melanoma patients showed safety and tolerability with local regression of the tumor mediated by antitumor immunity. The results suggest that HVJ-E might be a new treatment approach in patients with advanced melanoma. |
| doi_str_mv | 10.1007/s00262-020-02509-8 |
| format | Article |
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n
= 3 each) and received low and high doses of HVJ-E. Five of the six patients completed 4 weeks of follow-up evaluation; one patient discontinued treatment owing to progressive disease. Complete or partial responses were observed in 3 of 6 (50%) injected target lesions, 7 of 15 (47%) noninjected target lesions, and 10 of 21 (48%) target lesions. Induction of antitumor immunity was observed: activation of natural killer cells, a marked increase in interferon-γ levels in the peripheral blood, and infiltration of cytotoxic T cells into both injected and noninjected tumor lesions. Thus, intratumoral injection of HVJ-E in advanced melanoma patients showed safety and tolerability with local regression of the tumor mediated by antitumor immunity. The results suggest that HVJ-E might be a new treatment approach in patients with advanced melanoma.</description><identifier>ISSN: 0340-7004</identifier><identifier>EISSN: 1432-0851</identifier><identifier>DOI: 10.1007/s00262-020-02509-8</identifier><identifier>PMID: 32047956</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Antitumor activity ; Cancer Research ; Cell activation ; Cell fusion ; Cell Line, Tumor ; Clinical Trial Report ; Cytotoxicity ; Genetic Vectors - genetics ; Humans ; Immunology ; Injection ; Injections, Intralesional ; Lesions ; Lymphocytes T ; Medicine ; Medicine & Public Health ; Melanoma ; Melanoma - drug therapy ; Melanoma - immunology ; Metastases ; Natural killer cells ; Oncology ; Oncolytic Virotherapy - methods ; Patients ; Peripheral blood ; Protein biosynthesis ; RNA viruses ; Skin cancer ; Tumors ; Viral Envelope Proteins - genetics ; γ-Interferon</subject><ispartof>Cancer Immunology, Immunotherapy, 2020-06, Vol.69 (6), p.1131-1140</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c497t-79c89b028f814862761ca48df9b2993e1ad97bd9834c213d7f2e690bff2300373</citedby><cites>FETCH-LOGICAL-c497t-79c89b028f814862761ca48df9b2993e1ad97bd9834c213d7f2e690bff2300373</cites><orcidid>0000-0002-5239-8474 ; 0000-0002-0436-4296</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11027698/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11027698/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27923,27924,41487,42556,51318,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32047956$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kiyohara, Eiji</creatorcontrib><creatorcontrib>Tanemura, Atsushi</creatorcontrib><creatorcontrib>Nishioka, Megumi</creatorcontrib><creatorcontrib>Yamada, Mizuho</creatorcontrib><creatorcontrib>Tanaka, Aya</creatorcontrib><creatorcontrib>Yokomi, Akinori</creatorcontrib><creatorcontrib>Saito, Atsuhiro</creatorcontrib><creatorcontrib>Sakura, Kazuma</creatorcontrib><creatorcontrib>Nakajima, Toshihiro</creatorcontrib><creatorcontrib>Myoui, Akira</creatorcontrib><creatorcontrib>Sakurai, Toshiharu</creatorcontrib><creatorcontrib>Kawakami, Yutaka</creatorcontrib><creatorcontrib>Kaneda, Yasufumi</creatorcontrib><creatorcontrib>Katayama, Ichiro</creatorcontrib><title>Intratumoral injection of hemagglutinating virus of Japan-envelope vector yielded an antitumor effect for advanced melanoma: a phase I/IIa clinical study</title><title>Cancer Immunology, Immunotherapy</title><addtitle>Cancer Immunol Immunother</addtitle><addtitle>Cancer Immunol Immunother</addtitle><description>Hemagglutinating virus of Japan (HVJ; Sendai virus) is an RNA virus that has cell fusion activity. HVJ-envelope (HVJ-E) is a UV-irradiated HVJ particle that loses viral replication and protein synthesis activity but retains cell fusion activity. We recently reported that HVJ-E has antitumor effects on several types of tumors. Here, we describe the results of a first-in-human phase I/IIa study in patients with advanced melanoma, receiving intratumoral administration of HVJ-E. The primary aim was to evaluate the safety and tolerability of HVJ-E, and the secondary aim was to examine the objective tumor response and antitumor immunity. Six patients with stage IIIC or IV progressive malignant melanoma with skin or lymph metastasis were enrolled. Patients were separated into two groups (
n
= 3 each) and received low and high doses of HVJ-E. Five of the six patients completed 4 weeks of follow-up evaluation; one patient discontinued treatment owing to progressive disease. Complete or partial responses were observed in 3 of 6 (50%) injected target lesions, 7 of 15 (47%) noninjected target lesions, and 10 of 21 (48%) target lesions. Induction of antitumor immunity was observed: activation of natural killer cells, a marked increase in interferon-γ levels in the peripheral blood, and infiltration of cytotoxic T cells into both injected and noninjected tumor lesions. Thus, intratumoral injection of HVJ-E in advanced melanoma patients showed safety and tolerability with local regression of the tumor mediated by antitumor immunity. The results suggest that HVJ-E might be a new treatment approach in patients with advanced melanoma.</description><subject>Antitumor activity</subject><subject>Cancer Research</subject><subject>Cell activation</subject><subject>Cell fusion</subject><subject>Cell Line, Tumor</subject><subject>Clinical Trial Report</subject><subject>Cytotoxicity</subject><subject>Genetic Vectors - genetics</subject><subject>Humans</subject><subject>Immunology</subject><subject>Injection</subject><subject>Injections, Intralesional</subject><subject>Lesions</subject><subject>Lymphocytes T</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Melanoma</subject><subject>Melanoma - drug therapy</subject><subject>Melanoma - immunology</subject><subject>Metastases</subject><subject>Natural killer cells</subject><subject>Oncology</subject><subject>Oncolytic Virotherapy - methods</subject><subject>Patients</subject><subject>Peripheral blood</subject><subject>Protein biosynthesis</subject><subject>RNA viruses</subject><subject>Skin cancer</subject><subject>Tumors</subject><subject>Viral Envelope Proteins - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer Immunology, Immunotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kiyohara, Eiji</au><au>Tanemura, Atsushi</au><au>Nishioka, Megumi</au><au>Yamada, Mizuho</au><au>Tanaka, Aya</au><au>Yokomi, Akinori</au><au>Saito, Atsuhiro</au><au>Sakura, Kazuma</au><au>Nakajima, Toshihiro</au><au>Myoui, Akira</au><au>Sakurai, Toshiharu</au><au>Kawakami, Yutaka</au><au>Kaneda, Yasufumi</au><au>Katayama, Ichiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intratumoral injection of hemagglutinating virus of Japan-envelope vector yielded an antitumor effect for advanced melanoma: a phase I/IIa clinical study</atitle><jtitle>Cancer Immunology, Immunotherapy</jtitle><stitle>Cancer Immunol Immunother</stitle><addtitle>Cancer Immunol Immunother</addtitle><date>2020-06-01</date><risdate>2020</risdate><volume>69</volume><issue>6</issue><spage>1131</spage><epage>1140</epage><pages>1131-1140</pages><issn>0340-7004</issn><eissn>1432-0851</eissn><abstract>Hemagglutinating virus of Japan (HVJ; Sendai virus) is an RNA virus that has cell fusion activity. HVJ-envelope (HVJ-E) is a UV-irradiated HVJ particle that loses viral replication and protein synthesis activity but retains cell fusion activity. We recently reported that HVJ-E has antitumor effects on several types of tumors. Here, we describe the results of a first-in-human phase I/IIa study in patients with advanced melanoma, receiving intratumoral administration of HVJ-E. The primary aim was to evaluate the safety and tolerability of HVJ-E, and the secondary aim was to examine the objective tumor response and antitumor immunity. Six patients with stage IIIC or IV progressive malignant melanoma with skin or lymph metastasis were enrolled. Patients were separated into two groups (
n
= 3 each) and received low and high doses of HVJ-E. Five of the six patients completed 4 weeks of follow-up evaluation; one patient discontinued treatment owing to progressive disease. Complete or partial responses were observed in 3 of 6 (50%) injected target lesions, 7 of 15 (47%) noninjected target lesions, and 10 of 21 (48%) target lesions. Induction of antitumor immunity was observed: activation of natural killer cells, a marked increase in interferon-γ levels in the peripheral blood, and infiltration of cytotoxic T cells into both injected and noninjected tumor lesions. Thus, intratumoral injection of HVJ-E in advanced melanoma patients showed safety and tolerability with local regression of the tumor mediated by antitumor immunity. The results suggest that HVJ-E might be a new treatment approach in patients with advanced melanoma.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>32047956</pmid><doi>10.1007/s00262-020-02509-8</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-5239-8474</orcidid><orcidid>https://orcid.org/0000-0002-0436-4296</orcidid></addata></record> |
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| ispartof | Cancer Immunology, Immunotherapy, 2020-06, Vol.69 (6), p.1131-1140 |
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| source | MEDLINE; PubMed Central; SpringerLink Journals - AutoHoldings |
| subjects | Antitumor activity Cancer Research Cell activation Cell fusion Cell Line, Tumor Clinical Trial Report Cytotoxicity Genetic Vectors - genetics Humans Immunology Injection Injections, Intralesional Lesions Lymphocytes T Medicine Medicine & Public Health Melanoma Melanoma - drug therapy Melanoma - immunology Metastases Natural killer cells Oncology Oncolytic Virotherapy - methods Patients Peripheral blood Protein biosynthesis RNA viruses Skin cancer Tumors Viral Envelope Proteins - genetics γ-Interferon |
| title | Intratumoral injection of hemagglutinating virus of Japan-envelope vector yielded an antitumor effect for advanced melanoma: a phase I/IIa clinical study |
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