{"id":12244,"date":"2024-11-12T13:06:03","date_gmt":"2024-11-12T05:06:03","guid":{"rendered":"https:\/\/flcube.com\/?p=12244"},"modified":"2024-11-12T13:06:06","modified_gmt":"2024-11-12T05:06:06","slug":"abbisko-therapeutics-pimicotinib-meets-primary-endpoint-in-phase-iii-maneuver-study-for-tgct","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12244","title":{"rendered":"Abbisko Therapeutics’ Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT"},"content":{"rendered":"\n

hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256<\/a>) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). The study, designed to assess the efficacy and safety of pimicotinib in TGCT patients suitable for systemic therapy and not previously treated with anti-CSF1\/CSF1R treatment, has successfully met its primary endpoint.<\/p>\n\n\n\n

Phase III MANEUVER Study Results<\/strong>
At week 25, pimicotinib demonstrated an objective response rate (ORR) of 54.0%, a significant improvement over the placebo group’s 3.2% (p<0.0001). The study also achieved statistically and clinically significant improvements in all key secondary endpoints evaluated at week 25, including tumor volume score based ORR, active joint range of motion, stiffness, pain, and physical function. Pimicotinib was well-tolerated when administered orally once daily.<\/p>\n\n\n\n

Phase Ib Study Findings<\/strong>
The Phase Ib study evaluated the long-term efficacy and safety of pimicotinib, showing a best ORR of 85.0% with a median treatment duration of 20 months. This data underscores the drug’s potential for sustained efficacy in treating TGCT.<\/p>\n\n\n\n

Pimicotinib: Mechanism and Regulatory Milestones<\/strong>
Pimicotinib is an orally administered, highly potent, and selective small-molecule inhibitor of CSF-1R. Research indicates that blocking the CSF1\/CSF-1R signaling pathway can regulate and alter macrophage function, impacting various macrophage-related diseases. The drug has received breakthrough therapy designations (BTDs) from China’s Center for Drug Evaluation (CDE), the US FDA, and the European Medicine Agency (EMA) in 2022 and 2023, along with fast-track status in the US and Priority Medicines (PRIME) status in the European Union. In December of the previous year, Abbisko licensed pimicotinib to Merck KGaA for commercialization in Greater China and granted an option for global development.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the…<\/p>\n","protected":false},"author":1,"featured_media":12245,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[186,17,921],"class_list":["post-12244","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"],"yoast_head":"\nAbbisko Therapeutics' Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). 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