{"id":48557,"date":"2025-11-18T16:18:23","date_gmt":"2025-11-18T08:18:23","guid":{"rendered":"https:\/\/flcube.com\/?p=48557"},"modified":"2026-04-28T12:37:48","modified_gmt":"2026-04-28T04:37:48","slug":"beones-zanidatamab-achieves-pfs-os-wins-in-herizon-gea-01-phase-3-her2-positive-cancer-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48557","title":{"rendered":"BeOne&#8217;s Zanidatamab Achieves PFS &amp; OS Wins in HERIZON-GEA-01 Phase 3 HER2-Positive Cancer Trial"},"content":{"rendered":"\n<p><strong>BeOne Medicines Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/ONC:NASDAQ\">NASDAQ: ONC<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/6160:HKG\">HKG:\u202f6160<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/688235:SHA\">SHA: 688235<\/a>) announced its HER2\u2011targeted bispecific antibody <strong>zanidatamab (Ziihera)<\/strong> met both primary PFS and OS endpoints in the <strong>HERIZON\u2011GEA\u201101<\/strong> Phase\u202f3 trial for first\u2011line HER2\u2011positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), with the tislelizumab triple combo demonstrating a statistically significant survival benefit over trastuzumab plus chemotherapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trial-milestone\">Trial Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Product<\/strong><\/td><td>zanidatamab (Ziihera)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>HER2\u2011targeted bispecific antibody<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>HER2\u2011positive locally advanced\/metastatic GEA (gastric, GEJ, esophageal)<\/td><\/tr><tr><td><strong>Trial<\/strong><\/td><td>HERIZON\u2011GEA\u201101 Phase\u202f3<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>PFS and OS (both met)<\/td><\/tr><tr><td><strong>Control Arm<\/strong><\/td><td>trastuzumab + chemotherapy<\/td><\/tr><tr><td><strong>Combination Arms<\/strong><\/td><td>zanidatamab + chemotherapy; zanidatamab + tislelizumab + chemotherapy<\/td><\/tr><tr><td><strong>Key Result<\/strong><\/td><td>Triple combo shows statistically significant OS benefit; double combo shows OS trend<\/td><\/tr><tr><td><strong>Next Step<\/strong><\/td><td>Additional OS interim analysis for double combo mid\u20112026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> First\u2011in\u2011class HER2\u2011targeted bispecific antibody; brand name <strong>Ziihera<\/strong><\/li>\n\n\n\n<li><strong>Combination Strategy:<\/strong> Evaluated with <strong>tislelizumab (Tevimbra)<\/strong>, BeOne\u2019s PD\u20111 inhibitor, plus standard chemotherapy<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Dual HER2 epitope binding may overcome resistance vs. monoclonal antibodies like trastuzumab<\/li>\n\n\n\n<li><strong>Pipeline:<\/strong> HERIZON\u2011GEA\u201101 is the pivotal trial supporting global regulatory submissions<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-summary\">Clinical Evidence Summary<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Regimen<\/th><th>PFS Result<\/th><th>OS Result<\/th><\/tr><\/thead><tbody><tr><td><strong>zanidatamab + tislelizumab + chemo<\/strong><\/td><td>Highly statistically significant improvement vs control<\/td><td>Clinically meaningful and statistically significant improvement vs control<\/td><\/tr><tr><td><strong>zanidatamab + chemo<\/strong><\/td><td>Highly statistically significant improvement vs control<\/td><td>Clinically meaningful benefit, clear trend toward statistical significance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Note: Full hazard ratios and confidence intervals will be presented at an upcoming medical conference.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>GEA Market:<\/strong> ~1.1\u202fmillion new cases globally in 2025; HER2\u2011positive subset represents ~20\u201125% of gastric\/GEJ cancers<\/li>\n\n\n\n<li><strong>Standard of Care:<\/strong> Trastuzumab plus chemo remains first\u2011line; no HER2\u2011targeted therapy has shown OS benefit in combination with PD\u20111 inhibition in this setting<\/li>\n\n\n\n<li><strong>Regulatory Path:<\/strong> BeOne plans NDA submissions to <strong>NMPA, FDA, and EMA<\/strong> in H2\u202f2026 based on HERIZON\u2011GEA\u201101 results<\/li>\n\n\n\n<li><strong>Commercial Potential:<\/strong> Analysts project global peak sales potential of <strong>$2.5\u20113.5\u202fbillion<\/strong> if approved across major markets<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Positions ahead of <strong>Roche\u2019s trastuzumab<\/strong> and <strong>Daiichi\u2019s ENHERTU<\/strong> in first\u2011line HER2\u2011positive GEA<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding zanidatamab\u2019s clinical development, regulatory submissions, and commercial outlook. Actual results may differ materially due to risks including final data readouts, regulatory review outcomes, and market competition.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>BeOne Medicines Ltd. (NASDAQ: ONC, HKG:\u202f6160, SHA: 688235) announced its HER2\u2011targeted bispecific antibody zanidatamab (Ziihera)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48562,"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":[2092,16,17,29,847,3046,18,848],"class_list":["post-48557","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-beone-medicines","tag-cancer","tag-clinical-trial-results","tag-combination-therapy","tag-hkg-6160","tag-nasdaq-onc","tag-pd-1-l1","tag-sha-688235"],"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>BeOne&#039;s Zanidatamab Achieves PFS &amp; OS Wins in HERIZON-GEA-01 Phase 3 HER2-Positive Cancer Trial - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"BeOne Medicines Ltd. (NASDAQ: ONC, HKG:\u202f6160, SHA: 688235) announced its HER2\u2011targeted bispecific antibody zanidatamab (Ziihera) met both primary PFS and OS endpoints in the HERIZON\u2011GEA\u201101 Phase\u202f3 trial for first\u2011line HER2\u2011positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), with the tislelizumab triple combo demonstrating a statistically significant survival benefit over trastuzumab plus chemotherapy.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=48557\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeOne&#039;s Zanidatamab Achieves PFS &amp; OS Wins in HERIZON-GEA-01 Phase 3 HER2-Positive Cancer Trial\" \/>\n<meta property=\"og:description\" content=\"BeOne Medicines Ltd. (NASDAQ: ONC, HKG:\u202f6160, SHA: 688235) announced its HER2\u2011targeted bispecific antibody zanidatamab (Ziihera) met both primary PFS and OS endpoints in the HERIZON\u2011GEA\u201101 Phase\u202f3 trial for first\u2011line HER2\u2011positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), with the tislelizumab triple combo demonstrating a statistically significant survival benefit over trastuzumab plus chemotherapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48557\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-18T08:18:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-28T04:37:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1806.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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