{"id":48469,"date":"2025-11-17T19:35:37","date_gmt":"2025-11-17T11:35:37","guid":{"rendered":"https:\/\/flcube.com\/?p=48469"},"modified":"2025-11-17T19:35:38","modified_gmt":"2025-11-17T11:35:38","slug":"abbisko-therapeutics-reports-durable-response-in-phase-3-maneuver-study-for-pimicotinib-absk021-in-tgct","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48469","title":{"rendered":"Abbisko Therapeutics Reports Durable Response in Phase\u202f3 MANEUVER Study for Pimicotinib (ABSK021) in TGCT"},"content":{"rendered":"\n<p><strong>Abbisko Therapeutics Co.,\u202fLtd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2256:HKG\">HKG: 2256<\/a>) released long\u2011term efficacy, safety and patient\u2011reported outcome data from its global <strong>Phase\u202f3 MANEUVER<\/strong> study, evaluating the oral CSF\u20111R inhibitor <strong>pimicotinib (ABSK021)<\/strong> in patients with <strong>tenosynovial giant cell tumour (TGCT)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-highlights\">Study Highlights<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Result<\/th><\/tr><\/thead><tbody><tr><td><strong>Primary Endpoints (Week\u202f25)<\/strong><\/td><td><strong>ORR<\/strong>: 54.0\u202f% vs 3.2\u202f% placebo (P\u202f&lt;\u202f0.0001)<\/td><\/tr><tr><td><strong>Long\u2011Term ORR (Median&nbsp;Follow\u2011up\u202f14.3\u202fmonths)<\/strong><\/td><td>76.2\u202f% (95\u202f%\u202fCI: 63.8\u201186.0)<\/td><\/tr><tr><td><strong>Complete Responses<\/strong><\/td><td>4 patients (including 2 early\u2011switchers)<\/td><\/tr><tr><td><strong>Placebo\u2011to\u2011Pimicotinib Switch Cohort (Median\u202f8.5\u202fmonths)<\/strong><\/td><td>ORR: 64.5\u202f%<\/td><\/tr><tr><td><strong>Median Dose Intensity<\/strong><\/td><td>88.2\u202f%<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Predominantly Grade\u202f1\u20112 TEAEs; no new safety signals<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The data underscore <strong>pimicotinib\u2019s potency<\/strong> and confirm the drug\u2019s ability to produce <strong>robust, durable tumour regression<\/strong> over a 14\u2011month median follow\u2011up, with a progressive rise in objective response rate (ORR) from 54\u202f% at week\u202f25 to <strong>76.2\u202f%<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pimicotinib-product-overview\">Pimicotinib \u2013 Product Overview<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong> \u2013 Highly selective, potent inhibition of the <strong>colony\u2011stimulating factor\u20111 receptor (CSF\u20111R)<\/strong>, the key driver of macrophage\u2011mediated tumour growth in TGCT.<\/li>\n\n\n\n<li><strong>Administration<\/strong> \u2013 Once\u2011daily oral capsule, enabling systemic therapy for patients who would otherwise rely on surgical excision.<\/li>\n\n\n\n<li><strong>Regulatory Status<\/strong> \u2013 Granted <strong>priority review<\/strong> and <strong>breakthrough therapy designation (BTD)<\/strong> by the <strong>National Medical Products Administration (NMPA)<\/strong> in China in December\u202f2023.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-outlook\">Commercial Outlook<\/h2>\n\n\n\n<p>In December\u202f2023, Abbisko entered a global commercialization partnership with <strong>Merck KGaA<\/strong> (Merck), transferring worldwide marketing rights for pimicotinib. The agreement positions Merck to launch the drug across key markets, including the United States, Europe, and Japan, after Abbisko\u2019s <strong>NMPA breakthrough designation<\/strong> gives regulatory momentum in China.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>The information herein contains forward\u2011looking statements regarding clinical data, regulatory decisions and commercialization prospects. Actual outcomes may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111700094_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111700094_c.\"><\/object><a id=\"wp-block-file--media-e0288a39-38b6-4d7d-8241-775b51a876f7\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111700094_c.pdf\">2025111700094_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111700094_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e0288a39-38b6-4d7d-8241-775b51a876f7\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Abbisko Therapeutics Co.,\u202fLtd. (HKG: 2256) released long\u2011term efficacy, safety and patient\u2011reported outcome data from its&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48470,"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":[186,17,921,120],"class_list":["post-48469","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-abbisko-therapeutics","tag-clinical-trial-results","tag-hkg-2256","tag-merck"],"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>Abbisko Therapeutics Reports Durable Response in Phase\u202f3 MANEUVER Study for Pimicotinib (ABSK021) in TGCT - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Abbisko Therapeutics Co.,\u202fLtd. 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