{"id":16480,"date":"2025-08-18T16:58:50","date_gmt":"2025-08-18T13:58:50","guid":{"rendered":"https:\/\/www.cosmeticdermamedicine.gr\/?p=16480"},"modified":"2025-08-18T16:58:27","modified_gmt":"2025-08-18T13:58:27","slug":"skin-cancer-vaccine-melanoma","status":"publish","type":"post","link":"https:\/\/www.cosmeticdermamedicine.gr\/en\/skin-cancer-vaccine-melanoma","title":{"rendered":"Skin Cancer Vaccine Shows Encouraging Results"},"content":{"rendered":"\n<p>Melanoma, the most dangerous form of skin cancer, can progress rapidly and threaten life within a short period. Despite modern therapies such as immunotherapy, patients with advanced melanoma still need new, more effective treatment options. A candidate skin cancer vaccine, Cylembio from IO Biotech, showed particularly encouraging results in an extensive clinical study. Although the data did not fully meet the strict criteria for immediate approval, the company plans to apply with the U.S. Food and Drug Administration (FDA) by the end of 2025, fueling hopes that we are closer than ever to creating an effective vaccine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What is Cylembio and How Does it Work<\/h2>\n\n\n\n<p>Cylembio is an investigational vaccine that targets not only cancer cells but also specific immune system cells, such as those expressing the IDO1 and PD-L1 proteins. These cells produce surface molecules that inhibit the body&#8217;s defense mechanisms, allowing the tumor to survive and grow instead of being fought off. In clinical trials, it was administered together with <strong>Keytruda (pembrolizumab)<\/strong>, an already approved immunotherapy that helps the immune system recognize and destroy cancer cells.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Study Results<\/h2>\n\n\n\n<p>The significant Phase III clinical study compared two groups of patients:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Those who received <strong>the Cylembio vaccine combined with Keytruda<\/strong><\/li>\n\n\n\n<li>Those who received <strong>Keytruda alone<\/strong><\/li>\n<\/ul>\n\n\n\n<p>In the first group, the disease <strong>remained stable without showing signs of deterioration for approximately 19.5 months on average<\/strong> before recurring and progressing, while in the second group, this time was approximately 11 months. This means that the vaccine, in combination with immunotherapy, <strong>delayed disease progression by approximately 8 additional months<\/strong>.<\/p>\n\n\n\n<p>In a subgroup of patients who had not previously received similar treatment, the duration of disease stability reached 25 months, which is considered impressive for advanced melanoma. Additionally, preliminary data suggest that patients may live longer, although these data are expected to be confirmed in 2026.<\/p>\n\n\n\n<p>The treatment <strong>was well tolerated<\/strong> and did not cause new serious health problems.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Why Approval is Delayed<\/h2>\n\n\n\n<p>Despite the encouraging data, the result did not pass the strict statistical threshold set by the U.S. Food and Drug Administration (FDA) for approval of new therapies in Phase III, which is one stage before applying for approval. Simply put, the numbers showed clear improvement in 407 patients, but according to the FDA, there was a small probability that the result was coincidental. The study had few patients from the U.S. and mainly participants from Western Europe. The FDA is expected to request more data so that the sample is more representative of the American population.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other Investigational Vaccines for Melanoma<\/h2>\n\n\n\n<p>Cylembio is not the only anticancer vaccine in advanced stages of development. In parallel, pharmaceutical companies Moderna and MSD are conducting a Phase III clinical trial for mRNA-4157\/V940, a personalized vaccine designed specifically for each patient&#8217;s tumor, based on its genetic characteristics.<\/p>\n\n\n\n<p>In the results to date from the study, patients who had stage 3 or 4 melanoma removed and received the vaccine in combination with pembrolizumab showed approximately <strong>49% lower risk<\/strong> of recurrence or death, with follow-up of roughly three years, compared to those who received pembrolizumab alone. Researchers characterized the results as &#8220;extremely impressive.&#8221;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What This Means for Skin Cancer Patients<\/h2>\n\n\n\n<p>Melanoma represents a global challenge, with an estimated approximately <strong>330,000 new cases<\/strong> each year according to 2022 data. For patients with advanced melanoma, the possibility of approving a skin cancer vaccine that can extend life and delay disease progression is particularly hopeful. Even without immediate approval, the positive data leave open the possibility of soon having the first approval for such a vaccine in oncology, which, in combination with immunotherapies, will play a central role in the coming years in the treatment of skin cancer.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Melanoma, the most dangerous form of skin cancer, can progress rapidly and threaten life within a short period. Despite modern therapies such as immunotherapy, patients with advanced melanoma still need new, more effective treatment options. A candidate skin cancer vaccine, Cylembio from IO Biotech, showed particularly encouraging results in an extensive clinical study. Although the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16476,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-16480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/posts\/16480","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/comments?post=16480"}],"version-history":[{"count":0,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/posts\/16480\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/media\/16476"}],"wp:attachment":[{"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/media?parent=16480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/categories?post=16480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cosmeticdermamedicine.gr\/en\/wp-json\/wp\/v2\/tags?post=16480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}