Eli Lilly and Company announced today that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence [1]. This follows an initial marketing authorisation in 2018 for the treatment of metastatic breast cancer. Abemaciclib is an oral CDK4 and CDK6 inhibitor, a class of medicines which target and interrupt the cycle of cell growth and suppress the growth of tumours.

Approximately 20-30% of people with HR+, HER2- Early Breast Cancer develop incurable metastatic disease [2]. The authorisation of abemaciclib as adjuvant treatment will provide a treatment option for people with breast cancer that has a high risk of recurrence. It is based on results from the Phase 3 monarchE trial where adjuvant treatment with abemaciclib in combination with endocrine therapy decreased the risk of breast cancer recurrence by 32% in women who were identified as being at higher risk of recurrence defined by disease characteristics: either ≥4 positive axillary lymph nodes (pALN), or 1-3 pALN plus at least one of the following criteria: tumour size ≥5 cm or histologic Grade 3 [3] [4].

Breast cancer is the most common cancer among women worldwide [5]. Although the prognosis for HR+, HER2- early breast cancer is generally positive, 20-30 percent of patients could progress to incurable metastatic disease [2]. Risk of recurrence is greatest within the initial years post-diagnosis, particularly in patients with node-positive high-risk EBC [6].

MonarchE randomised 5,637 patients with HR+, HER2-, high risk EBC from more than 600 sites in 38 countries [7]. Patients were treated with abemaciclib 150mg tablets twice daily in combination with ET for two years (treatment period) or until meeting criteria for discontinuation [7]. Safety data from monarchE were consistent with the known safety profile of abemaciclib and no new safety signals were observed [6] [7].

1 European Medicines Agency (EMA) Verzenios | European Medicines Agency (europa.eu)

2 Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687-1717. DOI:10.1016/S0140-6736(05)66544-0 https://pubmed.ncbi.nlm.nih.gov/16262215/

3 European Medicines Agency Summary of Product Characteristics https://ec.europa.eu/health/documents/community-register/html/h1307.htm

4 Harbeck N, Rastogi P, Martin M, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. [published online October 14, 2021]. Annals of Oncology. DOI: https://doi.org/10.1016/j.annonc.2021.09.015

5 Ferlay J, Colombet M, Soerjomataram I et al. Cancer Statistics for the year 2020: An overview. International Journal of Cancer, 2021. https://doi.org/10.1002/ijc.33588

6 Cheng L, Swartz MD, Zhao H, et al. Hazard of recurrence among women after primary breast cancer treatment—a 10-year follow-up using data from SEER-Medicare . Cancer Epidemiol Biomarkers Prev. 2012;21:800-809.

7 Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE) [published online ahead of print, September 20, 2020]. J Clin Oncol. DOI:10.1200/JCO.20.02514