Lilly's Abemaciclib Phase 3 MONARCH plus Trial Meets Primary Endpoint in HR+/HER2- Advanced Breast Cancer

On September 19, Eli Lilly and Company announced that pre-specified interim analysis data from the MONARCH plus study demonstrated that the trial met its primary endpoint, confirming a statistically significant improvement in progression-free survival (PFS) with abemaciclib in combination with an aromatase inhibitor (anastrozole or letrozole) in postmenopausal women with HR+/HER2- advanced breast cancer, predominantly among Chinese patients. Furthermore, the key secondary endpoint also showed a significant prolongation of PFS in women who experienced disease progression after endocrine therapy and were treated with abemaciclib in combination with fulvestrant. The combination of abemaciclib with either an aromatase inhibitor (anastrozole or letrozole) or fulvestrant was well tolerated, and its safety profile was consistent with previous findings for abemaciclib.

Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated, “Three global clinical studies have confirmed that abemaciclib significantly prolongs progression-free survival (PFS) in patients with advanced breast cancer. In addition, China has concurrently participated in the global Phase 3 monarchE study, which is evaluating the clinical benefits of abemaciclib as adjuvant therapy for patients with early-stage breast cancer. Recently, Eli Lilly announced that the global MONARCH 2 study confirmed that treatment with abemaciclib in combination with fulvestrant significantly extends overall survival (OS) in premenopausal/perimenopausal and postmenopausal women with advanced breast cancer.[i] We now announce that abemaciclib is the first and currently only CDK4/6 inhibitor demonstrated to provide significant PFS benefits in a Phase 3 clinical study predominantly enrolling Chinese patients. These findings further solidify the therapeutic position of abemaciclib in the treatment of HR+/HER2- advanced breast cancer.”

Clinical study results from MONARCH plus will be presented at upcoming medical conferences. The design of the MONARCH plus clinical study was recently announced at the annual meeting of the Chinese Society of Clinical Oncology (CSCO) held on September 19, 2019; detailed efficacy and safety results will be presented at the 2019 European Society for Medical Oncology (ESMO) Annual Meeting on September 29. Eli Lilly plans to submit the clinical data from this study to Chinese regulatory authorities following the release of the interim analysis results from MONARCH plus.