China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on naïve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.
Trial Results
The interim analysis from this pivotal Phase III study demonstrated that the combination of culmerciclib and fulvestrant significantly reduced the risk of disease progression or death in first-line advanced breast cancer patients. The primary endpoint was met with both statistical difference and clinical significance, indicating the potential of this treatment regimen to improve outcomes for patients with this specific type of breast cancer.
Drug Mechanism and Safety
Culmerciclib is a novel cyclin-dependent kinase 2, 4, and 6 (CDK2/4/6) inhibitor with enhanced inhibitory effects on CDK2 compared to existing CDK4/6 inhibitors. The regimen was found to be generally safe and tolerable, positioning it as a promising option for patients who have previously been treated with hormonal therapy.
Regulatory and Commercial Outlook
Sino Biopharmaceutical is awaiting regulatory decisions in China for the use of culmerciclib in combination with fulvestrant. The positive results from this trial support the potential approval and commercialization of this treatment option, which could address an unmet need in the management of HR+/HER2- locally advanced or metastatic breast cancer.-Fineline Info & Tech
Leave a Reply