{"id":26145,"date":"2024-04-08T20:53:00","date_gmt":"2024-04-08T20:53:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4382330_CN82330_0"},"modified":"2024-04-08T20:53:00","modified_gmt":"2024-04-08T20:53:00","slug":"oral-report-the-positive-interim-analysis-results-from-the-phase-iii-clinical-study-of-akesos-cadonilimab-pd-1-ctla-4-bsab-plus-chemotherapy-as-first-line-treatment-for-advanced-gastric-cancer-pr","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=26145","title":{"rendered":"Oral report | The positive interim analysis results from the Phase III clinical study of Akeso&#8217;s Cadonilimab (PD-1\/CTLA-4 BsAb) plus chemotherapy as first-line treatment for advanced gastric cancer presented at 2024 AACR"},"content":{"rendered":"\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SAN DIEGO<\/span>, April 9, 2024 \/PRNewswire\/ &#8212; Akeso, Inc. (9926.HK) today announced that <b>the positive interim analysis results from <\/b>Phase III clinical study <b>of Cadonilimab (PD-1\/CTLA-4 BsAb) <\/b>combined with XELOX (capecitabine plus oxaliplatin) as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G\/GEJ) adenocarcinoma (AK104-302\/COMPASSION-15)&nbsp;were released presented in the form of oral presentation at the 2024 American Association for Cancer Research (AACR).<\/span><\/p>\n<p>The COMPASSION-15 is the world&#8217;s first Phase III clinical study of PD-1\/CTLA-4 bispecific antibody combined with chemotherapy as first-line treatment for gastric cancer. In COMPASSION-15 , the proportions of patients with PD-L1 CPS &lt;5 (PD-L1 low expression) and PD-L1 CPS &lt;1 (PD-L1 negative) &nbsp;in the intention-to-treat population (ITT) were 49.8% and 23%, respectively, which is much higher than that in previous Phase III clinical studies of immune checkpoint inhibitors combined regimens for first-line gastric cancer globally. Previous studies have shown that patients with PD-L1 low expression\/negative generally have poor efficacy with immunotherapy.<\/p>\n<p>As of the interim analysis, with a median follow-up of 18.7 months, the proportions of subsequent systemic treatment in the Cadonilimab combination therapy group and chemotherapy&nbsp;group were 36.4% vs 50.5%, respectively, and the proportions of subsequent treatment using PD-1\/PD-L1 inhibitors were 11.1% vs 21.6%, respectively.<\/p>\n<p>The results showed that regardless of PD-L1 expression, Cadonilimab combination therapy significantly prolonged patients&#8217; overall survival benefits and reduced the risk of death compared to chemotherapy, with outstanding benefits in objective response and long-term survival. Even for the patients with&nbsp;low PD-L1 expression, it also showed excellent efficacy, which is expected to compensate for the limited efficacy of PD-1 monotherapy for first-line treatment of low PD-L1 &nbsp;expression gastric cancer, providing a more comprehensive and efficient immunotherapy regimen for advanced gastric cancer patients.<\/p>\n<p>Cadonilimab plus&nbsp;chemo therapy significantly prolonged survival benefits&nbsp;as first-line treatment for advanced gastric cancer, comprehensively reducing the risk of progression\/death.<\/p>\n<p>l&nbsp; In the ITT population\uff0cthe median overall survival (mOS) &nbsp;was longer in the combination therapy&nbsp;group versus the chemotherapy&nbsp;group (HR=0.62 \uff0cmOS 15.0mo vs 10.8 mo; P&lt;0.001)\uff0cwith a 39% prolongation of mOS and a 38% reduction in the risk of death\uff1b<\/p>\n<ul type=\"disc\">\n<li><b>The OS benefits stratified by different CPS values were consistent with the overall population, with equally excellent efficacy in low PD-L1 expression: <\/b>\n<ul type=\"disc\">\n<li>When PD-L1 CPS\u22655, the&nbsp;mOS of Cadonilimab combination therapy group compared to the chemotherapy group was not reached vs 10.6 months, with a 44% reduction in the risk of death (HR=0.56, P&lt;0.001);<\/li>\n<li>When PD-L1 CPS&lt;5, the mOS was 14.8 months vs 11.1 months, with a 33.3% prolongation of mOS and a 30% reduction in the risk of death (HR=0.7, P=0.011);<\/li>\n<\/ul>\n<\/li>\n<li>The median progression-free survival (mPFS) in the ITT population was 7.0 months and 5.3 months, respectively, with a 32% prolongation of mPFS and a 47% reduction in the risk of disease progression (HR=0.53, P&lt;0.001).<\/li>\n<\/ul>\n<p><b>Cadonilimab combination therapy as first-line treatment for advanced gastric cancer is highly efficient in anti-tumor response, doubling the duration of response. <\/b><\/p>\n<ul type=\"disc\">\n<li>The objective response rates (ORR) of Cadonilimab combination therapy and chemotherapy were 65.2% and 48.9%, respectively, with a significant improvement in tumor treatment response with Cadonilimab combination therapy, increasing ORR by 33.3%;<\/li>\n<li>The median duration of response (mDOR) with Cadonilimab combination therapy was twice that of chemotherapy (8.8 months vs 4.4 months).<\/li>\n<\/ul>\n<p>Cadonilimab combination therapy significantly enhances long-term survival, with the advantage becoming more prominent with longer follow-up periods.<\/p>\n<ul type=\"disc\">\n<li>In the ITT population, the 12-month OS rates of Cadonilimab combination therapy vs chemotherapy were 57.3% vs 43.7%; when CPS\u22655, the 12-month OS rates were 58% vs 44.1%; when CPS&lt;5, the 12-month OS rates were 56.9% vs 45.1%;<\/li>\n<li>In the ITT population, the 18-month OS rates of Cadonilimab combination therapy vs chemotherapy were 45.8% vs 25.5%; when CPS\u22655, the 18-month OS rates were 51.2% vs 23.5%; when CPS&lt;5, the 18-month OS rates were 44.1% vs 27.5%;<\/li>\n<\/ul>\n<p>In <span class=\"xn-chron\">January 2024<\/span>, based on the results of the AK104-302\/COMPASSION-15 study, Akeso&#8217;s new drug application (NDA) for Cadonilimab combined with XELOX as first-line treatment for unresectable locally advanced or metastatic G\/GEJ adenocarcinoma has been successfully accepted.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SAN DIEGO, April 9, 2024 \/PRNewswire\/ &#8212; Akeso, Inc. (9926.HK) today announced that the positive interim analysis results from Phase III clinical study of Cadonilimab (PD-1\/CTLA-4 BsAb) combined with XELOX (capecitabine plus oxaliplatin) as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G\/GEJ) adenocarcinoma (AK104-302\/COMPASSION-15)&nbsp;were released presented in the form of [&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-26145","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>Oral report | The positive interim analysis results from the Phase III clinical study of Akeso&#039;s Cadonilimab (PD-1\/CTLA-4 BsAb) plus chemotherapy as first-line treatment for advanced gastric cancer presented at 2024 AACR - 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=26145\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Oral report | The positive interim analysis results from the Phase III clinical study of Akeso&#039;s Cadonilimab (PD-1\/CTLA-4 BsAb) plus chemotherapy as first-line treatment for advanced gastric cancer presented at 2024 AACR - My Blog\" \/>\n<meta property=\"og:description\" content=\"SAN DIEGO, April 9, 2024 \/PRNewswire\/ &#8212; Akeso, Inc. 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