{"id":44021,"date":"2025-10-21T21:18:57","date_gmt":"2025-10-21T13:18:57","guid":{"rendered":"https:\/\/flcube.com\/?p=44021"},"modified":"2025-10-21T21:18:58","modified_gmt":"2025-10-21T13:18:58","slug":"novartis-announces-first%e2%80%91in%e2%80%91class-phase-iii-data-for-lutetium%e2%80%91177-vipivotide-tetraxetan-in-psma%e2%80%91positive-metastatic-hormone%e2%80%91sensitive-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44021","title":{"rendered":"Novartis Announces First\u2011In\u2011Class Phase III Data for Lutetium\u2011177 Vipivotide Tetraxetan in PSMA\u2011Positive Metastatic Hormone\u2011Sensitive Prostate Cancer"},"content":{"rendered":"\n<p><strong>Novartis (<a href=\"https:\/\/www.google.com\/finance\/quote\/NVS:NYSE\">NYSE: NVS<\/a>)<\/strong> today disclosed the first data from its Phase\u202fIII <strong>PSMAddition<\/strong> trial of <strong>lutetium\u2011177 vipivotide tetraxetan<\/strong> (Lu\u2011177\u202fVIP) at the European Society for Medical Oncology (ESMO) 2025 Congress. The trial demonstrated that Lu\u2011177\u202fVIP, when combined with standard of care (SoC), produced a <strong>statistically significant and clinically meaningful improvement<\/strong> in patients with <strong>PSMA\u2011positive metastatic hormone\u2011sensitive prostate cancer (mHSPC)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-esmo-2025-findings\"><strong>Key ESMO 2025 Findings<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Lu\u2011177\u202fVIP\u202f+\u202fSoC<\/th><th>SoC Alone<\/th><th>Hazard Ratio (HR)<\/th><th>95\u202f% CI<\/th><\/tr><\/thead><tbody><tr><td><strong>Radiographic Progression\u2011Free Survival (rPFS)<\/strong><\/td><td>28\u202f% risk reduction<\/td><td>\u2014<\/td><td>0.72<\/td><td>0.58 \u2013 0.90<\/td><\/tr><tr><td><strong>Overall Survival (OS)<\/strong><\/td><td>Early positive trend<\/td><td>\u2014<\/td><td>0.84<\/td><td>0.63 \u2013 1.13*<\/td><\/tr><tr><td><strong>Complete Response (CR)<\/strong><\/td><td>57.1\u202f%<\/td><td>42.3\u202f%<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>Overall Response Rate (ORR)<\/strong><\/td><td>85.3\u202f%<\/td><td>80.8\u202f%<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><tr><td><strong>Time to mCRPC<\/strong><\/td><td>30\u202f% risk reduction<\/td><td>\u2014<\/td><td>0.70<\/td><td>0.58 \u2013 0.84<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>*OS follow\u2011up continues until data maturity.<\/p>\n\n\n\n<p>The rPFS benefit was consistent across all prespecified subgroups, and the combination regimen also <strong>delayed progression to metastatic castration\u2011resistant prostate cancer (mCRPC)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-impact\"><strong>Strategic Impact<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011In\u2011Class Targeted Radioligand Therapy<\/strong> \u2013 Lu\u2011177\u202fVIP delivers targeted beta\u2011particle radiation directly to PSMA\u2011expressing tumor cells, sparing healthy tissue.<\/li>\n\n\n\n<li><strong>Potential to Shift Treatment Paradigm<\/strong> \u2013 The data support the use of Lu\u2011177\u202fVIP earlier in the disease course, potentially improving outcomes for patients who are still hormone\u2011sensitive.<\/li>\n\n\n\n<li><strong>Regulatory Momentum<\/strong> \u2013 Positive Phase\u202fIII data bolster the regulatory strategy for global accelerated approval and support ongoing late\u2011stage studies.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\"><strong>Forward\u2011Looking Statements<\/strong><\/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>Novartis (NYSE: NVS) today disclosed the first data from its Phase\u202fIII PSMAddition trial of lutetium\u2011177&#8230;<\/p>\n","protected":false},"author":1,"featured_media":44023,"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":[106,16,17,140,865],"class_list":["post-44021","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-cancer","tag-clinical-trial-results","tag-novartis","tag-nyse-nvs"],"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>Novartis Announces First\u2011In\u2011Class Phase III Data for Lutetium\u2011177 Vipivotide Tetraxetan in PSMA\u2011Positive Metastatic Hormone\u2011Sensitive Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Novartis (NYSE: NVS) today disclosed the first data from its Phase\u202fIII PSMAddition trial of lutetium\u2011177 vipivotide tetraxetan (Lu\u2011177\u202fVIP) at the European Society for Medical Oncology (ESMO) 2025 Congress. The trial demonstrated that Lu\u2011177\u202fVIP, when combined with standard of care (SoC), produced a statistically significant and clinically meaningful improvement in patients with PSMA\u2011positive metastatic hormone\u2011sensitive prostate cancer (mHSPC).\" \/>\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=44021\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novartis Announces First\u2011In\u2011Class Phase III Data for Lutetium\u2011177 Vipivotide Tetraxetan in PSMA\u2011Positive Metastatic Hormone\u2011Sensitive Prostate Cancer\" \/>\n<meta property=\"og:description\" content=\"Novartis (NYSE: NVS) today disclosed the first data from its Phase\u202fIII PSMAddition trial of lutetium\u2011177 vipivotide tetraxetan (Lu\u2011177\u202fVIP) at the European Society for Medical Oncology (ESMO) 2025 Congress. 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