{"id":23841,"date":"2022-12-05T20:41:00","date_gmt":"2022-12-05T12:41:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23841"},"modified":"2025-01-30T01:38:22","modified_gmt":"2025-01-29T17:38:22","slug":"fudan-team-presents-ribociclib-phase-ii-bridging-study-results-at-esmo-asia","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23841","title":{"rendered":"Fudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia"},"content":{"rendered":"\n

A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. Ribociclib (trade name: Kisqali) is a cyclin-dependent kinases 4\/6 (CDK4\/6) inhibitor developed by Swiss giant Novartis (NYSE: NVS<\/a>). The drug was approved for marketing as a breast cancer treatment in the US and Europe in March and August of 2017 respectively, while Fineline Info & Tech<\/a> data shows an NDA for the drug was made in China in October 2021.<\/p>\n\n\n\n

Study Design and Objectives<\/strong>
The bridging study was designed to verify the results of the global Phase III MONALEESA-7 (pre-menopause) and MONALEESA-2 (post-menopause) studies as applicable to the Chinese population. Novartis initiated a Phase II bridging study for initial endocrine therapy \u00b1 ribociclib in mainland Chinese HR+\/HER2- premenopausal and postmenopausal patients with advanced breast cancer. The primary endpoint is progression-free survival (PFS), while the secondary endpoints are overall survival (OS), objective response rate (ORR), and safety.<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
The results showed that regardless of the patient’s menopausal status, compared with placebo+endocrine therapy, ribociclib+endocrine therapy showed PFS benefits. In the premenopausal cohort, the median PFS of the ribociclib + NSAI + OFS group vs the placebo group was 27.6 months vs 14.7 months, 12.9 months longer. In the postmenopausal cohort, the median PFS of the ribociclib + letrozole group versus the placebo group was not reached and 18.5 months, respectively. In addition, ORR improved in both the ribociclib+endocrine therapy cohorts. Overall safety was similar to known adverse reactions, in line with the results of MONALEESA-7 and MONALEESA-2 studies.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation…<\/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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,17,29,140,865,109],"class_list":["post-23841","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-results","tag-combination-therapy","tag-novartis","tag-nyse-nvs","tag-precision-medicine"],"yoast_head":"\nFudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. 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