{"id":28526,"date":"2025-03-03T17:18:52","date_gmt":"2025-03-03T09:18:52","guid":{"rendered":"https:\/\/flcube.com\/?p=28526"},"modified":"2025-03-03T17:18:54","modified_gmt":"2025-03-03T09:18:54","slug":"innovent-biologics-doses-first-patient-in-ibi363-melanoma-study-vs-keytruda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28526","title":{"rendered":"Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda"},"content":{"rendered":"\n

China-based Innovent Biologics, Inc. (HKG: 1801<\/a>) announced the first patient dosing in the pivotal regulatory study for its IBI363, a first-in-class PD-1\/IL-2\u03b1-bias bispecific antibody (BsAb) fusion protein. The trial compares IBI363 monotherapy with Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.<\/p>\n\n\n\n

Study Design<\/strong>
The randomized, multi-center pivotal study aims to assess the efficacy and safety of IBI363 versus pembrolizumab in the target patient population. The primary endpoint is progression-free survival (PFS), evaluated by an Independent Radiology Review Committee (IRRC) using RECIST v1.1 criteria. Previous clinical studies have shown promising efficacy signals for IBI363 in immunotherapy-na\u00efve melanoma patients.<\/p>\n\n\n\n

Drug Profile<\/strong>
IBI363 is a first-in-class drug independently developed by Innovent Biologics. It combines PD-1 blockade and selective IL-2 delivery, with the IL-2 arm engineered to enhance therapeutic effects while reducing side effects. Preclinical studies demonstrate strong anti-tumor activity in multiple models, including those resistant to PD-1 inhibitors, and a favorable safety profile.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory…<\/p>\n","protected":false},"author":1,"featured_media":28527,"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":[16,62,910,198,18],"class_list":["post-28526","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-1801","tag-innovent-biologics","tag-pd-1-l1"],"yoast_head":"\nInnovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Innovent Biologics, Inc. 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