US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph node positive early-stage breast cancer when used in combination with endocrine therapy, such as tamoxifen or aromatase inhibitors.
Abemaciclib’s Initial Approval and Clinical Relevance
Abemaciclib, a CDK4/6 inhibitor, was first approved to treat early-stage breast cancer in China in December 2021. It is specifically indicated for treating early breast cancer at high risk of recurrence. Previous studies have shown that after endocrine therapy alone, approximately 30% of high-risk patients still experience recurrence, which can lead to the progression of incurable metastatic diseases. These patients have a five-year recurrence risk three times higher than other non-high-risk patients.
Eligibility Based on monarchE Study
The extended indication is applicable to the high-risk population enrolled in the monarchE study, which includes patients with clinical pathological features such as four or more positive lymph nodes, or one to three positive lymph nodes with at least one of the following: tumor size of 5cm or larger, histological grade 3, or Ki-67 of 20% or higher.
Global Phase III monarchE Study and Results
The global, randomized, multi-center Phase III monarchE study enrolled 5,637 patients from 38 countries, including 501 from China. The latest results indicate that high-risk patients with early breast cancer who received endocrine therapy in combination with abemaciclib for two years after surgery showed clinically significant improvements and sustained benefits in terms of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) compared to those on endocrine therapy alone. The efficacy and safety of abemaciclib observed in Chinese patients with early breast cancer are consistent with those observed in the global population, and the safety spectrum is in line with those observed in Chinese clinical studies of advanced breast cancer.-Fineline Info & Tech
