{"id":30604,"date":"2024-10-16T11:02:00","date_gmt":"2024-10-16T11:02:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4532456_CN32456_0"},"modified":"2024-10-16T11:02:00","modified_gmt":"2024-10-16T11:02:00","slug":"igcs-late-breaking-abstract-and-the-lancet-akeso-published-positive-pfs-and-os-results-from-phase-3-first-line-study-of-cadonilimab-in-cervical-cancer","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=30604","title":{"rendered":"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer"},"content":{"rendered":"<div id=\"dvContent\" readability=\"89\">\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">HONG KONG<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Oct. 16, 2024<\/span><\/span> \/PRNewswire\/ &#8212; Akeso Biopharma (9926.HK)&nbsp; (&#8221; Akeso&#8221;, the &#8220;Company&#8221; ) announced positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16\/AK104-303). This study evaluated the efficacy of its independently developed PD-1\/CTLA-4 bispecific antibody, \u5f00\u5766\u5c3c\u00ae (cadonilimab), in combination with or without platinum-based chemotherapy and bevacizumab, compared to placebo with platinum-based chemotherapy and bevacizumab for first-line treatment of persistent, recurrent, or metastatic cervical cancer. These findings were presented as a Late-Breaking Abstract (LBA) in an oral session at the 2024 annual global meeting of the International Gynecologic Cancer Society (IGCS 2024).<\/p>\n<p>The principal investigator of the study, Professor <span class=\"xn-person\">Wu Xiaohua<\/span> from the Fudan University-affiliated Cancer Hospital, presented the results in an oral report, sharing these remarkable outcomes with global experts in gynecological oncology. Concurrently, the findings of the COMPASSION-16 study have been published in the medical journal The Lancet. This also highlights the study&#8217;s pivotal role in advancing the frontiers of international clinical cancer research and its potential role in cervical treatment options.<\/p>\n<p>The COMPASSION-16 study shows that the cadonilimab regimen, with or without bevacizumab, demonstrates promising efficacy in treating persistent, recurrent, or metastatic cervical cancer, addressing a critical unmet need for patients without access to bevacizumab. Additionally, cadonilimab offers significant benefits for all patients, regardless of PD-L1 expression status. This study highlights the clinical value and commercialization potential of cadonilimab to advance standard treatment for advanced cervical cancer.<\/p>\n<p>The primary endpoints of the COMPASSION-16 study were progression-free survival (PFS) and overall survival (OS) assessed by independent central imaging review (BICR) based on RECIST v1.1 criteria. A total of 445 patients were enrolled in the COMPASSION-16 study, with 27.9% of patients in the cadonilimab combined with chemotherapy \u00b1 bevacizumab treatment group having a CPS &lt; 1, compared to 24.2% in the control group.<\/p>\n<p>The study results indicate that the cadonilimab regimen significantly prolonged survival in the overall population, substantially decreasing the risk of disease progression and the risk of death.<\/p>\n<ul type=\"disc\">\n<li>In the intention-to-treat (ITT) population, the median overall survival (OS) for the cadonilimab regimen has not yet been reached, while the control group exhibited a median OS of 22.8 months (the hazard ratio [HR] 0.64, P=0.0011). The 12-month OS rates were 83.1% for the cadonilimab group compared to 73.7% for the control group, and the 24-month OS rates were 62.6% and 48.4%, respectively.<\/li>\n<li>In the ITT population, the median progression-free survival (PFS) for the cadonilimab regimen was 12.7 months, compared to 8.1 months in the control group (HR 0.62, P&lt;0.0001). The 12-month PFS rates were 51.1% and 35% , respectively. As the follow-up time extended (as of <span class=\"xn-chron\">April 30, 2024<\/span>), the benefits of the cadonilimab regimen became increasingly evident, with updated median PFS rates of 13.3 months and 8.2 months (HR 0.62).<\/li>\n<\/ul>\n<p>Regardless of whether it is combined with bevacizumab, the cadonilimab regimen shows a significant improvement in overall survival (OS).<\/p>\n<ul type=\"disc\">\n<li>In the absence of bevacizumab, the cadonilimab regimen is associated with a 50% reduction in the risk of death compared to the control group (OS HR 0.5), thereby effectively addressing the clinical need for patients who are ineligible for bevacizumab.<\/li>\n<\/ul>\n<p>Regardless of PD-L1 expression levels, cadonilimab regimen significantly reduces the risk across the entire patient population.<\/p>\n<ul type=\"disc\">\n<li>In the CPS &lt; 1 cohort, the&nbsp;cadonilimab regimen was associated with a 23% reduction in the risk of death (OS HR 0.77). In the CPS \u2265 1 cohort, there was a 31% reduction in the risk of death.(OS HR 0.69). Notably, in the CPS \u2265 10 cohort, the regimen led to a 32% reduction in the risk of death (OS HR 0.68).<\/li>\n<\/ul>\n<p>The cadonilimab regimen exhibits a high and sustained antitumor response.<\/p>\n<ul type=\"disc\">\n<li>The objective response rate (ORR) for the cadonilimab group was 82.9%, compared to 68.6% in the control group. The complete response (CR) rates were 35.6% and 22.9%, respectively. The median duration of response (DOR) was 13.2 months in the cadonilimab group, compared to 8.2 months in the control group.<\/li>\n<\/ul>\n<p>The combination of cadonilimab with chemotherapy \u00b1 bevacizumab has a manageable safety profile, with no new safety signals identified.<\/p>\n<\/p><\/div>\n<p>Source: Akeso, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>HONG KONG, Oct. 16, 2024 \/PRNewswire\/ &#8212; Akeso Biopharma (9926.HK)&nbsp; (&#8221; Akeso&#8221;, the &#8220;Company&#8221; ) announced positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16\/AK104-303). This study evaluated the efficacy of its independently developed PD-1\/CTLA-4 bispecific antibody, \u5f00\u5766\u5c3c\u00ae (cadonilimab), in combination with or without platinum-based chemotherapy and [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-30604","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=30604\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer - My Blog\" \/>\n<meta property=\"og:description\" content=\"HONG KONG, Oct. 16, 2024 \/PRNewswire\/ &#8212; Akeso Biopharma (9926.HK)&nbsp; (&#8221; Akeso&#8221;, the &#8220;Company&#8221; ) announced positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16\/AK104-303). This study evaluated the efficacy of its independently developed PD-1\/CTLA-4 bispecific antibody, \u5f00\u5766\u5c3c\u00ae (cadonilimab), in combination with or without platinum-based chemotherapy and [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=30604\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2024-10-16T11:02:00+00:00\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer\",\"datePublished\":\"2024-10-16T11:02:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604\"},\"wordCount\":661,\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604\",\"name\":\"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer - My Blog\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\"},\"datePublished\":\"2024-10-16T11:02:00+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=30604#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\",\"name\":\"My Blog\",\"description\":\"My WordPress Blog\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\",\"name\":\"admin_tony\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"caption\":\"admin_tony\"},\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?author=8\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer - My Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/transmediavictoria.net.au\/?p=30604","og_locale":"en_US","og_type":"article","og_title":"IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer - My Blog","og_description":"HONG KONG, Oct. 16, 2024 \/PRNewswire\/ &#8212; 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