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). 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 data shows an NDA for the drug was made in China in October 2021.
Study Design and Objectives
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 ± 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.
Clinical Trial Results
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
