SINO BIOPHARM: Phase III study data of the combination of Cumosil and Fulvestrant for first-line treatment of advanced breast cancer will be announced at ESMO 2025

According to the Zhitong Finance APP, SINO BIOPHARM (01177) announced that the group has presented the interim analysis results of the Phase III clinical study (CULMINATE-2) of the national Class 1 innovative drug Kumosily (CDK2/4/6 inhibitor) for first-line treatment of HR+/HER2- advanced breast cancer in the form of the latest key abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) Congress. CULMINATE-2 is the world's first Phase III clinical trial that has achieved positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy for HR+/HER2- advanced first-line breast cancer. This randomized, double-blind, multi-center parallel-controlled study aims to evaluate the efficacy and safety of Kumosily combined with Fulvestrant (experimental group) compared to placebo combined with Fulvestrant (control group) in patients with HR+/HER2- advanced breast cancer receiving initial endocrine treatment. The principal investigators are Academician Song Erwei from Sun Yat-sen University Sun Yat-sen Memorial Hospital and Professor Yin Yongmei from Jiangsu Provincial People's Hospital. Kumosily is a novel oral CDK2/4/6 inhibitor that exhibits varying degrees of inhibitory effects on CDK2, CDK4, and CDK6 kinases, particularly showing strong selective inhibition of CDK4 kinase, while having a weaker inhibitory effect on CDK6 kinase. This characteristic helps delay the clinical resistance issues associated with CDK4/6 inhibitors while reducing bone marrow suppression, potentially demonstrating breakthrough advantages in efficacy and safety, making it a potential Best-in-Class therapy. The Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has accepted the marketing application for Kumosily combined with Fulvestrant for the indication of HR+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine therapy in July 2024, and accepted its second indication application in July 2025 for initial endocrine treatment in patients with HR+/HER2- locally advanced or metastatic breast cancer. Currently, the group is also actively advancing the Phase III clinical trial of Kumosily for adjuvant treatment of breast cancer, having completed the enrollment of all subjects, and expects to submit a marketing application within the next two years. Kumosily is expected to comprehensively cover the entire treatment cycle of first-line, subsequent-line, and adjuvant therapy for HR+/HER2- breast cancer, providing innovative treatment options for more patients