{"id":43888,"date":"2025-10-20T19:39:00","date_gmt":"2025-10-20T11:39:00","guid":{"rendered":"https:\/\/flcube.com\/?p=43888"},"modified":"2025-10-20T19:39:01","modified_gmt":"2025-10-20T11:39:01","slug":"wuhan-yzy-biopharma-announces-interim-phase-ii-results-for-m701-in-malignant-pleural-effusion","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43888","title":{"rendered":"Wuhan YZY Biopharma Announces Interim Phase\u202fII Results for M701 in Malignant Pleural Effusion"},"content":{"rendered":"\n<p><strong>Wuhan YZY Biopharma Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2496:HKG\">HKG: 2496<\/a>)<\/strong> today disclosed interim data from its Phase\u202fII clinical trial of the bispecific antibody <strong>M701<\/strong> for the treatment of malignant pleural effusion (MPE) in advanced non\u2011small cell lung cancer (NSCLC) patients. 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-design-amp-patient-cohort\">Study Design &amp; Patient Cohort<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Population<\/strong> \u2013 54 NSCLC patients with symptomatic MPE, progressed after \u2265\u202f1 line of systemic therapy.<\/li>\n\n\n\n<li><strong>Randomization<\/strong> \u2013 1:1 into M701 (26 pts) vs. control (28 pts).<\/li>\n\n\n\n<li><strong>Control Therapy<\/strong> \u2013 Standard cisplatin\u2011based pleurodesis.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-efficacy-endpoints\">Key Efficacy Endpoints<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>M701<\/th><th>Control<\/th><th>Hazard Ratio (HR)<\/th><th>P\u2011value<\/th><\/tr><\/thead><tbody><tr><td><strong>Thoracentesis\u2011Free Survival (TFS)<\/strong><\/td><td>130\u202fdays (median)<\/td><td>85\u202fdays<\/td><td>0.80<\/td><td>0.542<\/td><\/tr><tr><td><strong>MPE Objective Response Rate (ORR)<\/strong> (overall)<\/td><td>72.7\u202f%<\/td><td>41.7\u202f%<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>Dyspnea Improvement<\/strong> (\u2265\u202f4\u202fweeks)<\/td><td>98\u202fdays sustained<\/td><td>\u2014<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>EpCAM\u207aCD45\u207b Tumor Cells in Pleural Fluid<\/strong> (post\u2011infusion)<\/td><td>Significant \u2193<\/td><td>No change<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-sub-group-insights\">Sub\u2011Group Insights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Driver\u2011Gene\u2011Negative Patients<\/strong> \u2013 Median TFS not reached vs. 44.5\u202fdays; HR\u202f&lt;\u202f0.01 (P\u202f&lt;\u202f0.001).<\/li>\n\n\n\n<li><strong>History of Intra\u2011Thoracic Chemotherapy<\/strong> \u2013 Median TFS 253\u202fdays vs. 72\u202fdays; HR\u202f0.31 (P\u202f=\u202f0.076).<\/li>\n\n\n\n<li><strong>MPE ORR in Sub\u2011Groups<\/strong> \u2013 72.7\u202f% (M701) vs. 41.7\u202f% (control).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-scientific-significance\">Scientific Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanistic Proof<\/strong> \u2013 Flow cytometry demonstrated a marked reduction of EpCAM\u207aCD45\u207b tumor cells in pleural fluid after M701 infusion, a change absent with cisplatin.<\/li>\n\n\n\n<li><strong>Clinical Impact<\/strong> \u2013 M701 offers a non\u2011invasive alternative to repeated thoracentesis, improving patient quality of life and reducing procedural burden.<\/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>Wuhan YZY Biopharma Co., Ltd. (HKG: 2496) today disclosed interim data from its Phase\u202fII clinical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43891,"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":[106,17,928,137],"class_list":["post-43888","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-clinical-trial-results","tag-hkg-2496","tag-yzy-biopharma"],"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>Wuhan YZY Biopharma Announces Interim Phase\u202fII Results for M701 in Malignant Pleural Effusion - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Wuhan YZY Biopharma Co., Ltd. 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(HKG: 2496) today disclosed interim data from its Phase\u202fII clinical trial of the bispecific antibody M701 for the treatment of malignant pleural effusion (MPE) in advanced non\u2011small cell lung cancer (NSCLC) patients. 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