Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25 per cent for People with HR+, HER2- High Risk Early Breast Cancer
Eli Lilly and Company (NYSE: LLY) announced Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25 per cent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.747; 95% CI: 0.598, 0.932; p = 0.0096). This statistically significant benefit was consistent across all pre-specified subgroups and corresponds to a 3.5 per cent difference between arms (92.2 per cent in the Verzenio arm and 88.7 per cent in the control arm) at two years. These results are from a preplanned interim analysis with 323 IDFS events observed in the intent-to-treat population across both arms, including 136 in the Verzenio arm and 187 in the control arm. The data were presented on September 20, 2020 in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress and simultaneously published in the Journal of Clinical Oncology.
Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed. At the time of analysis, approximately 70 per cent of patients in each arm were still on the two-year treatment period. The median follow up was approximately 15.5 months in both arms. The median duration on Verzenio was 14 months.
"When we are treating patients with high risk early stage breast cancer our goal is to decrease the risk of the cancer recurring and cure more patients," said Dr. Karen Gelmon, Medical Oncologist at BC Cancer Agency and Professor of Medicine at the University of British Columbia in Vancouver. "Results from monarchE are significant, as this study reports that Verzenio led to a statistically significant reduction in the risk of cancer recurrence suggesting it is an effective and well tolerated treatment for these patients."
monarchE randomized 5,637 patients with HR+, HER2- high risk early breast cancer from more than 600 sites in 38 countries, including 9 study sites in Canada. High risk was defined by cancer that spread to the lymph nodes, a large tumor size, or high cellular proliferation (as determined by tumor grade or Ki-67 index). Patients were treated for two years (treatment period) or until they met criteria for discontinuation. After the treatment period, all patients will continue ET for five to 10 years, as clinically indicated.
"Canadian women living with high risk early breast cancer want therapies that effectively treat breast cancer and reduce the risk of their cancer recurring," says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN). "Given that approximately 30 per cent of women living with high risk early breast cancer have a recurrence, having more treatment options means we continue to move in a direction toward enabling these women to live their lives to the fullest."
The addition of Verzenio to endocrine therapy also resulted in an improvement in distant relapse-free survival, or the time to developing cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 28 per cent (HR: 0.717; 95% CI: 0.559, 0.920), with the largest reductions occurring in rates of metastases to the liver and bone. This treatment benefit was consistent across all prespecified subgroups. Two-year distant relapse-free survival rates were 93.6 per cent in the Verzenio arm and 90.3 per cent in the control arm.
Overall survival results were immature and monarchE will continue through the completion date, estimated to be June 2027. At the time of the interim analysis, the IDFS results are considered definitive. All patients on monarchE will be followed until primary analysis and beyond to assess overall survival and other endpoints. Lilly will submit the monarchE data to regulatory authorities.
About the monarchE Study
monarchE is a Phase 3, multicenter, randomized, open-label trial that enrolled 5,637 patients with HR+, HER2- node-positive, high risk early breast cancer. Patients were randomized 1:1 to Verzenio (150 mg twice daily) plus standard adjuvant endocrine therapy or standard adjuvant endocrine therapy alone. Patients were treated for two years (treatment period) or until they met criteria for discontinuation. After the treatment period, all patients will continue on endocrine therapy for five to 10 years, as clinically indicated. The primary objective is invasive disease-free survival (IDFS) defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.
High risk was specifically defined as women (any menopausal status) and men with resected HR+, HER2- invasive early breast cancer with either ≥4 pathologically positive axillary lymph nodes (ALNs) or 1 to 3 positive ALNs and at least one of the following high-risk features: primary invasive tumor size ≥5 cm, histological grade 3 tumor, or central Ki-67 index ≥20%. If applicable, patients must have also completed adjuvant chemotherapy and radiotherapy prior to enrolling and have recovered from all acute side effects.