{"id":54245,"date":"2026-01-15T19:51:51","date_gmt":"2026-01-15T11:51:51","guid":{"rendered":"https:\/\/flcube.com\/?p=54245"},"modified":"2026-01-15T19:51:54","modified_gmt":"2026-01-15T11:51:54","slug":"jjs-tecvayli-shows-71-pfs-reduction-in-phase-3-majestec-9-for-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54245","title":{"rendered":"J&amp;J\u2019s TECVAYLI Shows 71% PFS Reduction in Phase\u202f3 MajesTEC\u20119 for Multiple Myeloma"},"content":{"rendered":"\n<p><strong>Johnson &amp; Johnson<\/strong> (J&amp;J, <a href=\"https:\/\/www.google.com\/finance\/quote\/JNJ:NYSE\">NYSE:\u202fJNJ<\/a>) announced positive topline results from the <strong>Phase\u202f3 MajesTEC\u20119 study<\/strong> of <strong>TECVAYLI (teclistamab\u2011cqyv)<\/strong>, demonstrating <strong>superior progression\u2011free survival (PFS)<\/strong> and <strong>overall survival (OS)<\/strong> compared to standard of care in patients with relapsed\/refractory multiple myeloma (RRMM) who are predominantly refractory to anti\u2011CD38 and lenalidomide therapies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory 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>Company<\/strong><\/td><td>Johnson &amp; Johnson (NYSE:\u202fJNJ)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>TECVAYLI (teclistamab\u2011cqyv)<\/td><\/tr><tr><td><strong>Study<\/strong><\/td><td>Phase\u202f3 MajesTEC\u20119<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>RRMM patients refractory to anti\u2011CD38 and lenalidomide<\/td><\/tr><tr><td><strong>Comparator<\/strong><\/td><td>Pomalidomide\/bortezomib\/dexamethasone (PVd) or carfilzomib\/dexamethasone (Kd)<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Progression\u2011free survival (PFS)<\/td><\/tr><tr><td><strong>Key Secondary<\/strong><\/td><td>Overall survival (OS)<\/td><\/tr><tr><td><strong>Results<\/strong><\/td><td>71% reduction in PFS risk, 40% reduction in OS risk<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Clinically manageable, consistent with known profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> First\u2011in\u2011class <strong>bispecific T\u2011cell engager (TCE) antibody<\/strong> binding to <strong>CD3 on T\u2011cells<\/strong> and <strong>BCMA on B\u2011cells<\/strong><\/li>\n\n\n\n<li><strong>Administration:<\/strong> <strong>Subcutaneous injection<\/strong>, offering convenience vs. IV\u2011infused CAR\u2011T therapies<\/li>\n\n\n\n<li><strong>Currently Approved:<\/strong> 4L+ RRMM in US (2022), EU (2023), and China (2024); this data supports <strong>2L+ expansion<\/strong><\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Only <strong>off\u2011the\u2011shelf BCMA\u2011targeted therapy<\/strong> demonstrating survival benefit in heavily pretreated population<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-phase-3-majestec-9\">Clinical Evidence \u2013 Phase\u202f3 MajesTEC\u20119<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>TECVAYLI<\/th><th>PVd\/Kd<\/th><th>Hazard Ratio<\/th><th>p\u2011Value<\/th><\/tr><\/thead><tbody><tr><td><strong>PFS (median)<\/strong><\/td><td><strong>Not reached<\/strong><\/td><td>9.5\u202fmonths<\/td><td><strong>0.29<\/strong><\/td><td>&lt;\u202f0.0001<\/td><\/tr><tr><td><strong>OS (median)<\/strong><\/td><td><strong>Not reached<\/strong><\/td><td>21.2\u202fmonths<\/td><td><strong>0.60<\/strong><\/td><td>0.003<\/td><\/tr><tr><td><strong>ORR<\/strong><\/td><td>78.4\u202f%<\/td><td>54.2\u202f%<\/td><td>\u2013<\/td><td>&lt;\u202f0.0001<\/td><\/tr><tr><td><strong>\u2265CR Rate<\/strong><\/td><td>45.2\u202f%<\/td><td>22.1\u202f%<\/td><td>\u2013<\/td><td>&lt;\u202f0.0001<\/td><\/tr><tr><td><strong>Grade\u202f\u2265\u202f3 CRS<\/strong><\/td><td>2.1\u202f%<\/td><td>\u2013<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Grade\u202f\u2265\u202f3 Neurotoxicity<\/strong><\/td><td>1.8\u202f%<\/td><td>\u2013<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-competitive-landscape\">Market Impact &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>US RRMM 2L+ Patients<\/strong><\/td><td>18,000<\/td><td>19,000<\/td><td>20,000<\/td><\/tr><tr><td><strong>TECVAYLI Market Share<\/strong><\/td><td>0\u202f%<\/td><td>22\u202f%<\/td><td>35\u202f%<\/td><\/tr><tr><td><strong>Annual Cost (USD)<\/strong><\/td><td>\u2013<\/td><td>$325,000<\/td><td>$310,000<\/td><\/tr><tr><td><strong>J&amp;J Revenue (US)<\/strong><\/td><td>\u2013<\/td><td>$1.29\u202fbillion<\/td><td>$2.17\u202fbillion<\/td><\/tr><tr><td><strong>Global Revenue<\/strong><\/td><td>\u2013<\/td><td>$2.8\u202fbillion<\/td><td>$4.5\u202fbillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitors:<\/strong><\/li>\n\n\n\n<li><strong>CAR\u2011T therapies:<\/strong> Abecma (BMS\/2seventy) and Carvykti (J&amp;J\/Legend) \u2013 require leukapheresis and manufacturing delay<\/li>\n\n\n\n<li><strong>Antibody\u2011drug conjugates:<\/strong> Blenrep (GSK) \u2013 returned to GSK after failure<\/li>\n\n\n\n<li><strong>Other bispecifics:<\/strong> Elranatamab (Pfizer) \u2013 pending approval<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> TECVAYLI\u2019s <strong>subcutaneous administration<\/strong> and <strong>immediate availability<\/strong> provide <strong>competitive edge<\/strong> over CAR\u2011T logistics<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning-amp-next-steps\">Strategic Positioning &amp; Next Steps<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Filing:<\/strong> J&amp;J plans <strong>sNDA submission<\/strong> to <strong>FDA<\/strong> in <strong>Q2\u202f2026<\/strong> for 2L+ indication; <strong>PDUFA target<\/strong> <strong>Q1\u202f2027<\/strong><\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Established global supply chain with <strong>three production sites<\/strong> (US, EU, China) capable of supporting <strong>50,000+ patients annually<\/strong><\/li>\n\n\n\n<li><strong>Commercial Readiness:<\/strong> 250\u2011person US oncology sales force already detailing TECVAYLI for 4L+; seamless expansion to 2L+ upon approval<\/li>\n\n\n\n<li><strong>Pipeline Synergy:<\/strong> Data supports potential expansion to <strong>1L transplant\u2011ineligible<\/strong> patients and <strong>combination with Darzalex<\/strong> in earlier lines<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory submissions, commercial forecasts, and market penetration for TECVAYLI. Actual results may differ due to FDA review outcomes, competitive dynamics, and market access challenges.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Johnson &amp; Johnson (J&amp;J, NYSE:\u202fJNJ) announced positive topline results from the Phase\u202f3 MajesTEC\u20119 study of&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[17,150,149,28,858],"class_list":["post-54245","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-jj","tag-johnson-johnson","tag-multi-specific-antibodies","tag-nyse-jnj"],"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>J&amp;J\u2019s TECVAYLI Shows 71% PFS Reduction in Phase\u202f3 MajesTEC\u20119 for Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Johnson &amp; Johnson (J&amp;J, NYSE:\u202fJNJ) announced positive topline results from the Phase\u202f3 MajesTEC\u20119 study of TECVAYLI (teclistamab\u2011cqyv), demonstrating superior progression\u2011free survival (PFS) and overall survival (OS) compared to standard of care in patients with relapsed\/refractory multiple myeloma (RRMM) who are predominantly refractory to anti\u2011CD38 and lenalidomide therapies.\" \/>\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=54245\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"J&amp;J\u2019s TECVAYLI Shows 71% PFS Reduction in Phase\u202f3 MajesTEC\u20119 for Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"Johnson &amp; Johnson (J&amp;J, NYSE:\u202fJNJ) announced positive topline results from the Phase\u202f3 MajesTEC\u20119 study of TECVAYLI (teclistamab\u2011cqyv), demonstrating superior progression\u2011free survival (PFS) and overall survival (OS) compared to standard of care in patients with relapsed\/refractory multiple myeloma (RRMM) who are predominantly refractory to anti\u2011CD38 and lenalidomide therapies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=54245\" \/>\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=\"2026-01-15T11:51:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-15T11:51:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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