2020-09-23| Trials & Approvals

Lilly’s Trailblazer Makes Headway in Breast Cancer Therapy

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Breast cancer is the most common cancer among women worldwide, but approximately 90% of all breast cancer is diagnosed at an early stage. Nearly 70% of all breast cancers are classified as hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) subtype. Such a subtype has about a 30% cancer recurrence and potentially leads to incurable metastatic diseases through the spread to the lymph nodes or the biology of the tumor itself. There is thus an imperative need to innovate new and more effective treatments for such a large population.

On September 20, Eli Lilly announced in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress that Verzenio (abemaciclib), in combination with standard adjuvant endocrine therapy (ET), achieved the primary endpoint of invasive disease-free survival (IDES). The regimen reduced the risk of developing metastatic disease by 28%. The largest reductions occurred in the liver and bone, so Lily decided to submit the clinical data to the regulatory authorities before 2020. The clinical results were also published in the Journal of Clinical Oncology simultaneously.



Being an inhibitor of cyclin-dependent kinase (CDK4 & 6), Verzenio is Lilly’s first solid oral dosage form to be produced in continuous manufacturing, a cutting-edge manufacturing technology in the pharmaceutical industry. Verzenio can effectively stifle cell cycle progression and cell proliferation by inhibiting retinoblastoma protein (Rb) phosphorylation and blocking cell cycle progression from G1 to S phase, and then leading to senescence and apoptosis of cells. According to the clinical evidence, daily Verzenio administration caused tumor size reduction and comparable concentrations of Verzenio and active metabolites to that of unbound plasma in the cerebrospinal fluid due to Verzenio’s overcoming blood-brain barrier capability.

“[Verzenio] is a major milestone for people living with high-risk HR+, HER2- early breast cancer – potentially one of the most notable treatment advances in the last two decades for this population of breast cancer patients,” said Stephen Johnston, M.D., Ph.D., Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust (London, U.K.) and lead investigator for the monarchE trial.


monarchE Clinical Study & Results

monarchE is a Phase 3, multicenter, randomized, open-label trial involving 5637 participants with HR+, HER2-, node-positive, and high risk of early diagnosed breast cancer from more than 600 sites across 38 countries. High-risk early breast cancer included metastasis to lymph nodes, larger tumor size, or higher rate of cellular proliferation based upon histological tumor grade or central Ki-67 index, as well as those that have been previously treated with chemotherapy or radiotherapy and have fully recovered from all acute adverse events.

The 5637 patients were evenly randomized into two groups receiving 150mg Verzenio twice daily plus standard adjuvant ET or standard ET only for two years or until meeting criteria for discontinuation. After the two-year treatment period, all patients will continue on ET for another 5-10 years. The primary objective is to examine how long before any cancer recurs or a new one develops by IDES, based on the Standard Definitions for Efficacy Endpoints (STEEP) criteria. The secondary objective measures distant relapse-free survival, overall survival, safety, pharmacokinetics, and health outcomes.

The two-year treatment showed remarkable consistency across all pre-specified subgroups defined during the trials, with a distant relapse-free survival rate of 93.6% in the Verzenio arm and 90.3% in the control arm. However, the overall survival rate remained immature, and monarchE will be continued until June 2027.


Safety Analysis

Verzenio could be administered in combination with an aromatase inhibitor for postmenopausal women previously treated with ET or with fulvestrant for women struggling with disease progression after ET. There were many adverse events reported, including diarrhea, neutropenia, interstitial lung disease and/or pneumonitis, hepatotoxicity, venous thromboembolic events, etc. Nevertheless, 70% of patients in each arm stayed through the two-year treatment. The median follow-up was about 15.5 months in both arms, while the median follow-up was 14 months for Verzenio alone. It was also promising when safety data from monarchE were consistent with the known safety profile of Verzenio, and no new safety signals were observed.

Related Article: Roche’s Multifaceted Drug, Tecentriq Registers Mixed Results in Breast Cancer Patients



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