{"id":23483,"date":"2024-02-09T13:46:20","date_gmt":"2024-02-09T18:46:20","guid":{"rendered":"https:\/\/www.mesotheliomahope.com\/?p=23483"},"modified":"2024-02-09T16:15:34","modified_gmt":"2024-02-09T21:15:34","slug":"uv1-cancer-vaccine-fast-tracked-by-fda","status":"publish","type":"post","link":"https:\/\/www.mesotheliomahope.com\/blog\/uv1-cancer-vaccine-fast-tracked-by-fda\/","title":{"rendered":"FDA Fast-Tracks UV1 Cancer Vaccine for Mesothelioma Patients"},"content":{"rendered":"<p>On February 5, 2024, the U.S. Food and Drug Administration (FDA) approved a Fast Track designation for the UV1 cancer vaccine in combination with ipilimumab and nivolumab for patients with inoperable <a href=\"\/mesothelioma\/\">mesothelioma<\/a>, an aggressive cancer caused by asbestos exposure.<\/p>\n<p>The Fast Track designation allows the FDA to accelerate the review of the vaccine developed by biotechnology company Ultimovacs ASA, <strong>possibly allowing UV-1 to reach patients sooner<\/strong>.<\/p>\n<p><strong>This designation streamlines the drug review process with:<\/strong><\/p>\n<ul>\n<li>The ability to submit data and related materials in segments as they are completed<\/li>\n<li>More frequent meetings and communications with the FDA to resolve questions<\/li>\n<li>Prioritized review by the FDA<\/li>\n<\/ul>\n<blockquote><p>\u201cWe are pleased that the FDA has granted Fast Track designation for UV1. [It has] demonstrated a positive safety profile and encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors ipilimumab and nivolumab in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.\u201d<\/p>\n<footer><cite><strong>&ndash; Carlos de Sousa, CEO of Ultimovacs<\/strong><\/cite><\/footer><\/blockquote><style type=\"text\/css\">blockquote{margin:40px 0;padding:0px 15px 0px 60px;position:relative;background-color:#fff}blockquote:before{content:\"\\e99d\";color:#fff;background-color:#0FAEBF;font-size:30px;font-family:\"mesohope\" !important;position:absolute;left:0;top:0;width:50px;height:50px;line-height:50px;text-align:center;border-radius:50%}blockquote p{margin:0}blockquote footer cite{font-size:inherit;line-height:26px;font-style:normal}@media screen and (min-width: 1024px){blockquote{padding:0px 90px 0px 85px}blockquote:before{font-size:35px;width:60px;height:60px;line-height:60px;left:0}}<\/style>\n<p>The news follows positive results from a clinical trial that combined the UV1 vaccine with the <a href=\"\/treatment\/immunotherapy\/\">immunotherapy<\/a> medications Opdivo\u00ae and Yervoy\u00ae. The trio of drugs successfully improved overall survival compared to those who only received immunotherapy.<\/p>\n<p>Learn more about the UV1 vaccine and its success in the mesothelioma clinical trial below.<\/p>\n<h2>Understanding the Therapeutic UV1 Vaccine<\/h2>\n<p>The immunotherapy drug combination of <a href=\"\/treatment\/immunotherapy\/opdivo-yervoy\/\">nivolumab (Opdivo) and ipilimumab (Yervoy)<\/a> was approved by the FDA as a first-line (standard) treatment for pleural mesothelioma after studies showed it improved survival. However, this combination alone doesn\u2019t work for all patients, leading researchers to explore a new approach.<\/p>\n<p>One of the challenges in treating mesothelioma has been identifying specific targets for treatment. Ultimovacs designed its UV1 vaccine to target the enzyme telomerase, which is a known biomarker, or sign, of cancer.<\/p>\n<p>In fact, telomerase is present in 85-90% of cancers regardless of how far tumors have spread, meaning that <strong>UV1 may work as a universal vaccine<\/strong> for various types and stages of cancers.<\/p>\n<p>Similarly to other types of immunotherapy treatment, mesothelioma vaccines aim to help the body\u2019s immune system fight off cancer cells. While no mesothelioma vaccines have been approved by the FDA yet, this Fast Track designation for UV1 could soon lead to it becoming the first approved <a href=\"\/treatment\/immunotherapy\/mesothelioma-vaccine\/\">cancer vaccine for mesothelioma<\/a>.<\/p>\n<p>A mesothelioma specialist can help you access the latest treatments being tested in clinical trials. Use our <strong>Free Doctor Match<\/strong> to get connected with a specialist now.<\/p>\n<h2>About the NIPU Phase II Clinical Trial<\/h2>\n<p>The FDA cited the positive results of UV1\u2019s phase II clinical trial sponsored by Oslo University as the reason why it approved the request for Fast Track designation. The trial compared UV1 in combination with immunotherapy as a second-line treatment for <a href=\"\/mesothelioma\/pleural\/\">pleural mesothelioma<\/a>.<\/p>\n<div class=\"did-you-know icon-bell\"><style type=\"text\/css\">.did-you-know{background:#F3F2F0;border-radius:10px;margin:40px 0;padding:20px 20px 20px 80px;position:relative}.did-you-know:before{position:absolute;left:20px;top:20px;width:45px;height:45px;background:#0FAEBF;border-radius:50px;color:#fff;text-align:center;line-height:45px;font-size:27px}.did-you-know .heading{font-size:24px;color:#100134;padding:10px 0;display:block;margin:0 0 5px}.did-you-know h2,.did-you-know .h2,.did-you-know h3,.did-you-know .h3{font-size:24px;line-height:1.14}@media screen and (min-width: 1024px){.did-you-know{padding:25px 25px 25px 90px}.did-you-know:before{left:25px;top:25px}.did-you-know .heading{padding:8px 0}.did-you-know h2,.did-you-know .h2,.did-you-know h3,.did-you-know .h3{font-size:24px;line-height:1.14}}<\/style><strong class=\"heading\">Did You Know?<\/strong><p>Second-line treatments are used when a patient\u2019s cancer does not respond well to other standard therapies.<\/p>\n<\/div>\n<p>Known as NIPU (nivolumab and Ipilimumab plus\/minus UV1 vaccination), the clinical trial involves 118 pleural mesothelioma patients whose cancer had already spread after they received <a href=\"\/treatment\/chemotherapy\/\">chemotherapy<\/a> as a first-line treatment.<\/p>\n<p><strong>From there, the patients were split into 2 groups, with:<\/strong><\/p>\n<ul>\n<li>All patients getting Opdivo (nivolumab) every 2 weeks and Yervoy (ipilimumab) every 6 weeks until the cancer spread, the side effects became too much, or 2 years passed<\/li>\n<li>An experimental group receiving an additional 8 injections of the UV1 cancer vaccine within the first 3 months of care<\/li>\n<\/ul>\n<p>By splitting the groups this way, researchers were able to test the influence of immunotherapy on their own and then with the UV1 vaccine for mesothelioma.<\/p>\n<h3>Results of the NIPU Phase II Clinical Trial<\/h3>\n<p>The results of the phase II NIPU <a href=\"\/treatment\/clinical-trials\/\">clinical trial<\/a> were revealed at the European Society for Medical Oncology Congress in October 2023.<\/p>\n<div class=\"quick-facts-shortcode\"><style type=\"text\/css\">.quick-facts-shortcode{border-radius:0 10px 10px 0;border:1px solid #E6E7EC;margin:40px 0;overflow:hidden;padding:20px 20px 20px 24px;position:relative;font-size:17px;box-shadow:0 20px 20px rgba(34,34,34,0.03)}.quick-facts-shortcode:before{content:\" \";position:absolute;top:0;bottom:0;width:4px;height:100%;left:0;background:linear-gradient(180deg, #0FAEBF 0%, #fff 100%)}.quick-facts-shortcode .quick-facts-shortcode-heading{color:#100134;display:block;font-size:22px;margin-bottom:20px}.quick-facts-shortcode .content ul{margin-left:24px;margin-bottom:0}.quick-facts-shortcode .content ul li:before{width:6px;height:6px;top:10px;left:-22px;-webkit-border-radius:50%;-moz-border-radius:50%;border-radius:50%;border:none;background:#F38A6B}.quick-facts-shortcode .content ul li:last-child{margin-bottom:0}.quick-facts-shortcode .content p:empty{display:none}@media screen and (min-width: 1024px){.quick-facts-shortcode{padding:25px 25px 25px 30px}.quick-facts-shortcode-heading{font-size:22px;margin-bottom:20px}}<\/style><strong class=\"quick-facts-shortcode-heading\">When used as an add-on to treatment with nivolumab and ipilimumab, the UV1 cancer vaccine resulted in:<\/strong><div class=\"content\"><ul>\n<li>27% improved survival and a <a href=\"\/mesothelioma\/prognosis\/life-expectancy\/\">life expectancy<\/a> of 15.4 months \u2014 4 months longer than immunotherapy alone<\/li>\n<li>31% of patients in the UV1 group achieved partial or complete remission, as opposed to the 16% in the group that didn\u2019t receive the vaccine<\/li>\n<li>No additional side effects or toxicities from the combination of drugs<\/li>\n<\/ul>\n<\/div><\/div>\n<p>These results are great news for patients who are not eligible for surgery and who may not have a response to chemotherapy. Additionally, a Fast Track designation could bring this treatment option to even more patients soon.<\/p>\n<h2>Find the Right Mesothelioma Treatment for You<\/h2>\n<p>While researchers will continue to monitor the study participants in future phases of the trial, the significance of these results to mesothelioma patients can\u2019t be understated.<\/p>\n<p><strong>If you or a loved one have been diagnosed with mesothelioma, our team may be able to help you: <\/strong><\/p>\n<ul>\n<li>Find mesothelioma doctors, cancer centers, or support groups nearby<\/li>\n<li>Understand your <a href=\"\/treatment\/\">treatment<\/a> options as well as possible symptoms or side effects<\/li>\n<li>Pursue <a href=\"\/legal\/compensation\/\">mesothelioma compensation<\/a> that can help you afford medical care and other expenses<\/li>\n<\/ul>\n<p>A mesothelioma diagnosis can feel overwhelming, but you don\u2019t have to go through this alone. Call <a href=\"tel:+18666088933\" title=\"Click to call (866) 608-8933\" class=\"in-content-tel-link\" data-ce-category=\"Click to Call\" data-ce-label=\"(866) 608-8933\">(866) 608-8933<\/a> now to get help from our caring Patient Advocates.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On February 5, 2024, the U.S. Food and Drug Administration (FDA) approved a Fast Track designation for the UV1 cancer vaccine in combination with ipilimumab and nivolumab for patients with inoperable mesothelioma, an aggressive cancer caused by asbestos exposure. The Fast Track designation allows the FDA to accelerate the review of the vaccine developed by&hellip;<\/p>\n","protected":false},"author":35,"featured_media":23482,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[118],"tags":[276,146,275],"class_list":["post-23483","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mesothelioma-treatment","tag-cancer-vaccine","tag-immunotherapy","tag-uv1-cancer-vaccine"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/posts\/23483","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/users\/35"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/comments?post=23483"}],"version-history":[{"count":0,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/posts\/23483\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/media\/23482"}],"wp:attachment":[{"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/media?parent=23483"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/categories?post=23483"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.mesotheliomahope.com\/wp-json\/wp\/v2\/tags?post=23483"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}