{"id":43895,"date":"2025-10-20T19:49:18","date_gmt":"2025-10-20T11:49:18","guid":{"rendered":"https:\/\/flcube.com\/?p=43895"},"modified":"2025-10-20T19:49:19","modified_gmt":"2025-10-20T11:49:19","slug":"akeso-announces-landmark-phase-iii-results-for-ivonescimab-in-first%e2%80%91line-sq%e2%80%91nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43895","title":{"rendered":"Akeso Announces Landmark Phase\u202fIII Results for IVONESCIMAB in First\u2011Line Sq\u2011NSCLC"},"content":{"rendered":"\n<p><strong>Akeso Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/9926:HKG\">HKG: 9926<\/a>)<\/strong> today disclosed the results of its global first\u2011in\u2011class bispecific antibody <strong>ivonescimab<\/strong> (PD\u20111\/VEGF) in combination with chemotherapy versus <strong>tislelizumab + chemotherapy<\/strong> as first\u2011line therapy for advanced <strong>squamous non\u2011small cell lung cancer (sq\u2011NSCLC)<\/strong>. The data from the registrational Phase\u202fIII study <strong>AK112\u2011306 \/ HARMONi\u20116<\/strong> were presented at the <strong>Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress\u202f2025<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-findings\">Key Findings<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Ivonescimab + Chemo<\/th><th>Tislelizumab + Chemo<\/th><th>Statistical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>Median Progression\u2011Free Survival (mPFS)<\/strong><\/td><td>11.14\u202fmonths<\/td><td>6.90\u202fmonths<\/td><td>HR\u202f0.60, <strong>P\u202f&lt;\u202f0.0001<\/strong><\/td><\/tr><tr><td><strong>PD\u2011L1 Stratified Benefit<\/strong><\/td><td>Significant benefit regardless of PD\u2011L1 status<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Liver Metastases \/ Metastatic Sites<\/strong><\/td><td>Benefit maintained across sub\u2011groups<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>No new safety signals; comparable TRAEs, irAEs, Grade\u202f3 bleeding<\/td><td>Comparable<\/td><td>\u2013<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Safety<\/strong> \u2013 Treatment\u2011related serious adverse events, immune\u2011related adverse events, and Grade\u202f3 bleeding events were similar to the tislelizumab arm. The most common adverse reactions were chemotherapy\u2011related myelosuppression.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-context\">Strategic Context<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011in\u2011Class<\/strong> \u2013 Ivonescimab is the world\u2019s first approved bispecific antibody that couples <strong>PD\u20111 blockade with VEGF inhibition<\/strong>, delivering a synergistic \u201cimmuno\u2011oncology\u202f+\u202fanti\u2011angiogenesis\u201d mechanism.<\/li>\n\n\n\n<li><strong>Regulatory Milestones<\/strong> \u2013 Approved by China\u2019s National Medical Products Administration (NMPA) in May\u202f2024 for locally advanced or metastatic non\u2011squamous NSCLC post\u2011EGFR\u2011TKI progression; added to the National Reimbursement Drug List in November\u202f2024.<\/li>\n\n\n\n<li><strong>Market Impact<\/strong> \u2013 The Phase\u202fIII data position ivonescimab as a compelling first\u2011line option for sq\u2011NSCLC, potentially reshaping the therapeutic landscape and expanding Akeso\u2019s global footprint.<\/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>Akeso Inc. (HKG: 9926) today disclosed the results of its global first\u2011in\u2011class bispecific antibody ivonescimab&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43896,"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":[106,360,16,17,850,18],"class_list":["post-43895","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-akeso-biopharma","tag-cancer","tag-clinical-trial-results","tag-hkg-9926","tag-pd-1-l1"],"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>Akeso Announces Landmark Phase\u202fIII Results for IVONESCIMAB in First\u2011Line Sq\u2011NSCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Akeso Inc. (HKG: 9926) today disclosed the results of its global first\u2011in\u2011class bispecific antibody ivonescimab (PD\u20111\/VEGF) in combination with chemotherapy versus tislelizumab + chemotherapy as first\u2011line therapy for advanced squamous non\u2011small cell lung cancer (sq\u2011NSCLC). The data from the registrational Phase\u202fIII study AK112\u2011306 \/ HARMONi\u20116 were presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress\u202f2025.\" \/>\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=43895\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akeso Announces Landmark Phase\u202fIII Results for IVONESCIMAB in First\u2011Line Sq\u2011NSCLC\" \/>\n<meta property=\"og:description\" content=\"Akeso Inc. (HKG: 9926) today disclosed the results of its global first\u2011in\u2011class bispecific antibody ivonescimab (PD\u20111\/VEGF) in combination with chemotherapy versus tislelizumab + chemotherapy as first\u2011line therapy for advanced squamous non\u2011small cell lung cancer (sq\u2011NSCLC). 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