{"id":4761,"date":"2025-07-22T08:37:21","date_gmt":"2025-07-22T08:37:21","guid":{"rendered":"https:\/\/medical.biomarin.com\/en-us\/?page_id=4761"},"modified":"2026-01-07T19:45:31","modified_gmt":"2026-01-07T19:45:31","slug":"malignancy-vector-integration","status":"publish","type":"page","link":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/malignancy-vector-integration\/","title":{"rendered":"Malignancy (vector integration)"},"content":{"rendered":"<div id=\"acf-block-645511272e5db\" class=\"hero hero-no-overlay hero-small-title\">\n            <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-drop.png?v=1.20);\"><\/div>\n\t    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-drop-Mobile.png?v=1.20);\"><\/div>\n    \t<div class=\"overlay\"><\/div>\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"hero-content\">\n\t\t\t    \t\t\t        <ul class=\"breadcrumb\">\n\t\t\t            \t\t\t                                                                        <li><a href=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/\">Hemophilia A<\/a><\/li>\n                            \t\t\t                                                                        <li><a href=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\">Valoctocogene roxaparvovec safety<\/a><\/li>\n                            \t\t\t                                                                        <li>Malignancy (vector integration)<\/li>\n                            \t\t\t            \t\t\t        <\/ul>\n\t\t\t    \t\t\t\t\t\t\t\t\t\t\t\t    <h1>Malignancy (vector integration) \n<\/h1>\n\t\t\t\t\t\t\t\t\t\t\t\t\n                <p class=\"inline-buttons\">\n                                                        <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n\n<div id=\"acf-block-645512ae5ba05\" class=\"block wrapped-content bg-band bg-band-primary block-zero-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-645512ae5bb64\" class=\"block-wysiwyg\">\n            <h2>State of Knowledge Summary<\/h2>\n<ul>\n<li>Integration with theoretical risk of associated adverse events remains a safety concern with adeno-associated virus (AAV) <span class=\"glossaryLink\"  aria-describedby=\"tt\"  data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Gene therapies&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;&amp;lt;!-- wp:paragraph --&amp;gt;Gene therapy aims to treat or correct genetic disorders by introducing or modifying genetic material within a person&amp;#039;s cells. This is achieved by transferring therapeutic genes into the body to replace faulty or missing genes, allowing cells to produce functional proteins and restore normal cellular function. &amp;lt;sup&amp;gt;5&amp;lt;\/sup&amp;gt; (See references on the Pipeline and Clinical Development Programs page)&amp;lt;br\/&amp;gt;&amp;lt;!-- \/wp:paragraph --&amp;gt;&lt;\/div&gt;\"  data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex='0' role='link'>gene therapies<\/span>.<sup>1,2<\/sup><\/li>\n<li>To date, there is no evidence to suggest that AAV gene therapy directly causes cancer. However, there are risks associated with AAV gene therapy, and long-term safety data are still being collected.<sup>3<\/sup><\/li>\n<li>To date, no treatment-related events attributed to vector integration have been observed with valoctocogene roxaparvovec or analogs.<sup>4-9<\/sup><\/li>\n<li>No cases of malignancy reported in valoctocogene roxaparvovec clinical trials have been determined to be related to treatment with valoctocogene roxaparvovec.<sup>6,8<\/sup><\/li>\n<li>The clinical relevance of individual vector insertional events is not known to date.<sup>3,12<\/sup><\/li>\n<li>While AAV vector DNA integration has been observed in humans, non-human primates (NHPs), and dogs, there have been no reports of resulting genotoxicity or oncogenesis.<sup>13-15<\/sup><\/li>\n<li>Overall, while the long-term safety of AAV gene therapy is still being evaluated, there is currently no evidence to suggest that AAV gene therapy directly causes cancer.<sup>16<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6489aa17cf1cd\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6489aa17cf334\" class=\"block-wysiwyg\">\n            <p>Valoctocogene roxaparvovec is designed to deliver therapeutic transgene to the hepatocyte nucleus, where it is expected to persist as extra-chromosomal episomes; however, valoctocogene roxaparvovec can insert into the DNA of human body cells.<sup>7,17,18<\/sup> The clinical relevance of individual vector insertional events is not known to date.<\/p>\n    <\/div>\n\n<figure id=\"acf-block-6489aa17cf526\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/07\/Malignancy-with-Integrated-AAV-genome-11JUN23-v01-1900x1058.png\" alt=\"Graphic outlining malignancy\"\/>            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-645514ad0bc61\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-645514ad0d39d\" class=\"block-wysiwyg\">\n            <ul>\n<li>BioMarin has performed integration analyses on non-human primates samples, liver samples from clinical trial patients, healthy and tumor-containing tissue from a trial patient with a parotid gland acinar cell carcinoma, and enriched bone marrow cells and peripheral blood lymphoblasts from a trial patient with B-cell acute lymphoblastic leukemia.<sup>17-19<\/sup>\n<ul>\n<li>Across these analyses, the rate of integration for valoctocogene roxaparvovec was low and comparable on a per cell basis to those exposed with natural AAV, where no epidemiological risk has been identified.<sup>18,20<\/sup><\/li>\n<li>No clonal expansion or uneven growth of cells containing integration events was observed in any of the samples analyzed.<sup>18<\/sup><\/li>\n<\/ul>\n<\/li>\n<li>No cancers determined to be caused by valoctocogene roxaparvovec have been observed in any clinical trials and no cancers have been observed in non-clinical studies with valoctocogene roxaparvovec.<sup>6,8,19<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6455154840072\" class=\"block call-to-action block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t    \t\t\t\t\t\t        <p>You may report adverse events to BioMarin at&#xA0;<a href=\"mailto:drugsafety@bmrn.com\" target=\"_blank\" rel=\"noopener noreferrer\">drugsafety@bmrn.com<\/a>. You are encouraged to report negative adverse events of prescription drugs to the FDA. Visit&#xA0;<a class=\"external_link\" href=\"http:\/\/www.fda.giv\/medwatch\" target=\"_blank\" rel=\"noopener noreferrer\">www.fda.gov\/medwatch<\/a>, or call&#xA0;<a href=\"tel:1-800-FDA-1088\">1-800-FDA-1088<\/a>.<\/p>\n\t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6488286ecabf6\" class=\"block next-previous\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n            <div class=\"link link-prev\">\n                                    <p><a class=\"button button-text button-arrow button-arrow-left\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/liver-health\/\" target=\"_self\">Liver Health<\/a><\/p>\n                            <\/div>\n            <div class=\"link link-next\">\n                                    <p><a class=\"button button-text button-arrow\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/thromboembolism\/\" target=\"_self\">Thromboembolism Summary<\/a><\/p>\n                            <\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6481afaff0fe9\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>References:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>European Medicines Agency (EMA). Reflection paper on management of clinical risks deriving from insertional mutagenesis. EMA Committee for Advanced Therapies (CAT). 19 April 2013.\n<\/span><\/li>\n                                                                                                                                                <li><span>Sabatino DE, et al. Evaluating the state of science for AAV integration: An integrated perspective. Mol Ther. 2022;30(8):2646-63\n<\/span><\/li>\n                                                                                                                                                <li><span>Burdett T and Nuseibach S. Changing trends in the development of AAV-based <span class=\"glossaryLink\"  aria-describedby=\"tt\"  data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Gene therapies&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;&amp;lt;!-- wp:paragraph --&amp;gt;Gene therapy aims to treat or correct genetic disorders by introducing or modifying genetic material within a person&amp;#039;s cells. This is achieved by transferring therapeutic genes into the body to replace faulty or missing genes, allowing cells to produce functional proteins and restore normal cellular function. &amp;lt;sup&amp;gt;5&amp;lt;\/sup&amp;gt; (See references on the Pipeline and Clinical Development Programs page)&amp;lt;br\/&amp;gt;&amp;lt;!-- \/wp:paragraph --&amp;gt;&lt;\/div&gt;\"  data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex='0' role='link'>gene therapies<\/span>: a meta-analysis of past and present therapies. Gene Ther. 2023;30:323-335.\n<\/span><\/li>\n                                                                                                                                                <li><span>Rangarajan S, Walsh L, Lester W, et al. AAV5-Factor VIII Gene Transfer in Severe Hemophilia A. N Engl J Med. 2017;377(26):2519-2530.\n<\/span><\/li>\n                                                                                                                                                <li><span>Ozelo MC, Mahlangu J, Pasi KJ, et al. Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A. N Engl J Med. 2022;386(11):1013-1025.\n<\/span><\/li>\n                                                                                                                                                <li><span>Mahlangu J, Leavitt AD, Raheja P, et al. Efficacy and safety of valoctocogene roxaparvovec for severe hemophilia A 5 years after gene transfer in GENEr8-1 [presentation]. Presented at the World Federation of Hemophilia Comprehensive Care Summit (WFH-CCS). April 23-25, 2025; Dubai, United Arab Emirates.\n<\/span><\/li>\n                                                                                                                                                <li><span>Pasi KJ, Rangarajan S, Mitchell N, et al. Multiyear Follow-up of AAV5-hFVIII-SQ Gene Therapy for Hemophilia A. N Engl J Med. 2020;382(1):29-40.\n<\/span><\/li>\n                                                                                                                                                <li><span>Laffan M, Rangarajan S, Lester W, et al. Hemostatic results for up to 6 years following treatment with valoctocogene roxaparvovec, an AAV5-hFVIII-SQ gene therapy for severe hemophilia A [presentation]. Presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress. July 9-13, 2022; London, United Kingdom.\n<\/span><\/li>\n                                                                                                                                                <li><span>BioMarin Press Release, January 2023\n<\/span><\/li>\n                                                                                                                                                <li><span>Kuzmin DA, Shutova MV, Johnston NR, et al. The clinical landscape for AAV <span class=\"glossaryLink\"  aria-describedby=\"tt\"  data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Gene therapies&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;&amp;lt;!-- wp:paragraph --&amp;gt;Gene therapy aims to treat or correct genetic disorders by introducing or modifying genetic material within a person&amp;#039;s cells. This is achieved by transferring therapeutic genes into the body to replace faulty or missing genes, allowing cells to produce functional proteins and restore normal cellular function. &amp;lt;sup&amp;gt;5&amp;lt;\/sup&amp;gt; (See references on the Pipeline and Clinical Development Programs page)&amp;lt;br\/&amp;gt;&amp;lt;!-- \/wp:paragraph --&amp;gt;&lt;\/div&gt;\"  data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex='0' role='link'>gene therapies<\/span>. Nat Rev Drug Discov. 2021;20(3):173-174.\n<\/span><\/li>\n                                                                                                                                                <li><span>Mullard A. Gene therapy community grapples with toxicity issues, as pipeline matures. Nat Rev Drug Discov. 2021;20(11):804-805.\n<\/span><\/li>\n                                                                                                                                                <li><span>Kishimoto TK and Samulski RJ. Addressing high dose AAV toxicity &#x2013; &#x2018;one and done&#x2019; or &#x2018;slower and lower&#x2019;? Expert Opinion on Biol Ther. 2022;22(9):1067-71.\n<\/span><\/li>\n                                                                                                                                                <li><span>Gil-Farina I, Fronza R, Kaeppel C, et al. Recombinant AAV Integration Is Not Associated With Hepatic Genotoxicity in Nonhuman Primates and Patients. Mol Ther. 2016;24(6):1100-1105.\n<\/span><\/li>\n                                                                                                                                                <li><span>Batty P, Fong S, Franco M, et al. Frequency, location and nature of AAV vector insertions after long term follow up of FVIII transgene delivery in a hemophilia A dog model [poster]. Presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtural Congress. July 12-14, 2020.\n<\/span><\/li>\n                                                                                                                                                <li><span>Nguyen GN, Everett JK, Kafle S, et al. A long-term study of AAV gene therapy in dogs with hemophilia A identifies clonal expansions of transduced liver cells. Nat Biotechnol. 2021;39(1):47-55.\n<\/span><\/li>\n                                                                                                                                                <li><span>Mary Ann Liebert, Inc. Does AAV-based gene delivery cause liver cancer? The debate heats up. 26 May 2016. Medical Xpress.\n<\/span><\/li>\n                                                                                                                                                <li><span>Fong S, Yates B, Sihn CR, et al. Interindividual variability in transgene mRNA and protein production following adeno-associated virus gene therapy for hemophilia A. Nat Med. 2022;28(4):789-797.\n<\/span><\/li>\n                                                                                                                                                <li><span>Eggan K. Molecular Characterization of FVIII Recombinant AAV5 encoding FVIII after Human administration [presentation]. Presented at the Annual Meeting of the European Society of Gene &amp; Cell Therapy (ESGCT). October 11-14, 2022; Edinburgh, UK.\n<\/span><\/li>\n                                                                                                                                                <li><span>Sullivan L, Zahn M, Gil Farina I, et al. Rare Genomic Integrations of AAV5-hFVIII-SQ Occur without Evidence of Clonal Activation or Gene-Specific Targeting [poster]. Presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. May 11-May 14, 2021.\n<\/span><\/li>\n                                                                                                                                                <li><span>Qin W, Xu G, Tai PWL, et al. Large-scale molecular epidemiological analysis of AAV in a cancer patient population. Oncogene. 2021;40(17):3060-3071.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":4754,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4761","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Malignancy (vector integration) | BioMarin Medical<\/title>\n<meta name=\"description\" content=\"Learn more about Malignancy (vector integration)\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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