{"id":43870,"date":"2025-10-20T19:21:03","date_gmt":"2025-10-20T11:21:03","guid":{"rendered":"https:\/\/flcube.com\/?p=43870"},"modified":"2025-10-20T19:21:03","modified_gmt":"2025-10-20T11:21:03","slug":"alphamab-oncology-announces-interim-phase-iii-results-for-anbenitamab-in-her2%e2%80%91positive-gastric-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43870","title":{"rendered":"Alphamab Oncology Announces Interim Phase\u202fIII Results for Anbenitamab in HER2\u2011Positive Gastric Cancer"},"content":{"rendered":"\n<p><strong>Alphamab Oncology (<a href=\"https:\/\/www.google.com\/finance\/quote\/9966:HKG\">HKG: 9966<\/a>)<\/strong> today disclosed the first interim data from its Phase\u202fIII study evaluating <strong>anbenitamab injection (KN026)<\/strong>, in combination with chemotherapy, as a second\u2011line and beyond treatment for HER2\u2011positive gastric cancer, including gastro\u2011oesophageal junction adenocarcinoma. The results were presented at the <strong>European Society for Medical Oncology (ESMO) Congress\u202f2025<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-highlights\">Study Highlights<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Anbenitamab + Chemo<\/th><th>Control (Chemo\u202f+\u202fPlacebo)<\/th><th>Hazard Ratio (HR)<\/th><th>P\u2011value<\/th><\/tr><\/thead><tbody><tr><td><strong>Median Progression\u2011Free Survival (PFS)<\/strong><\/td><td>7.1\u202fmo<\/td><td>2.7\u202fmo<\/td><td>0.25<\/td><td>5.44\u202f\u00d7\u202f10\u207b\u00b9\u00b2<\/td><\/tr><tr><td><strong>Median Overall Survival (OS)<\/strong><\/td><td>19.6\u202fmo*<\/td><td>11.5\u202fmo<\/td><td>0.29<\/td><td>1.56\u202f\u00d7\u202f10\u207b\u2076<\/td><\/tr><tr><td><strong>Objective Response Rate (ORR)<\/strong><\/td><td>55.8\u202f%<\/td><td>10.8\u202f%<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>Disease\u2011Control Rate (DCR)<\/strong><\/td><td>80.0\u202f%<\/td><td>41.9\u202f%<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>Median Duration of Response (DoR)<\/strong><\/td><td>8.2\u202fmo<\/td><td>2.9\u202fmo<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>*OS data are immature.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong>Statistical Impact<\/strong> \u2013 The anbenitamab cohort experienced a <strong>75\u202f% reduction<\/strong> in the risk of disease progression or death (HR\u202f0.25) and a <strong>71\u202f% reduction<\/strong> in the risk of death (HR\u202f0.29) compared with control, with highly significant P\u2011values (P\u202f&lt;\u202f0.00001).<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-amp-development-profile\">Product &amp; Development Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Anbenitamab (KN026)<\/strong> \u2013 A HER2 bispecific antibody engineered on Alphamab\u2019s proprietary Fc heterodimer platform (CRIB).<\/li>\n\n\n\n<li><strong>Mechanism<\/strong> \u2013 Simultaneous binding to two non\u2011overlapping HER2 epitopes, blocking downstream HER2 signaling.<\/li>\n\n\n\n<li><strong>Collaborators<\/strong> \u2013 Developed in partnership with <strong>Shanghai JMT Biotechnology Co., Ltd.<\/strong>, a wholly\u2011owned subsidiary of CSPC Pharmaceutical Group.<\/li>\n\n\n\n<li><strong>Regulatory Milestone<\/strong> \u2013 In September\u202f2025, the <strong>NMPA<\/strong> accepted the first New Drug Application (NDA) for anbenitamab for HER2\u2011positive gastric cancer.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Edge<\/strong> \u2013 The interim data position anbenitamab as a compelling second\u2011line therapy in a high\u2011need, high\u2011mortality patient population.<\/li>\n\n\n\n<li><strong>Strategic Expansion<\/strong> \u2013 Successful outcomes will support global launch plans and potential expansion into other HER2\u2011positive malignancies.<\/li>\n\n\n\n<li><strong>Investor Interest<\/strong> \u2013 The robust clinical results and regulatory acceptance are expected to enhance Alphamab\u2019s valuation and attract additional partnership opportunities.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alphamab Oncology (HKG: 9966) today disclosed the first interim data from its Phase\u202fIII study evaluating&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43873,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[106,187,16,17,854],"class_list":["post-43870","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-alphamab-oncology","tag-cancer","tag-clinical-trial-results","tag-hkg-9966"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Alphamab Oncology Announces Interim Phase\u202fIII Results for Anbenitamab in HER2\u2011Positive Gastric Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Alphamab Oncology (HKG: 9966) today disclosed the first interim data from its Phase\u202fIII study evaluating anbenitamab injection (KN026), in combination with chemotherapy, as a second\u2011line and beyond treatment for HER2\u2011positive gastric cancer, including gastro\u2011oesophageal junction adenocarcinoma. 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