A new therapeutic option for patients with early breast cancer

The European Commission approves the use of abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor-positive (HR) early stage breast cancer and non-expressing human epidermal growth factor receptor 2 (HER2) type 2 receptor with lymph node metastasis, with a high risk of relapse.

Abemaciclib is the first and only inhibitor of CDK4 and 6 in the therapy of HR +, HER2- early breast cancer with a high risk of recurrence. The positive opinion of the European Medicines Agency was based on the results of the monarchE ¹ Phase 3 trial, which met its primary endpoint in the second intermediate efficacy analysis, showing statistically significant improvement in free survival from Invasive Disease (IDFS).

For the monarchE study of 2 patient cohorts, 5,637 female and male patients with HR +, HER2- early breast cancer at high risk of recurrence were randomized from more than 600 centers in 38 countries. The European Medicines Agency decision for abemaciclib was made according to the high risk criteria for cohort 1. High risk of relapse in cohort 1 was defined on the basis of clinical and pathomorphological features:

• presence of ≥4 metastatic axillary lymph nodes or
• presence of 1-3 metastatic axillary lymph nodes and at least one of the following criteria met:
  • size of neoplastic lesion ≥5 cm or
  • grade of histological malignancy G3.

Patients were treated with abemaciclib in combination with hormone therapy for two years or until treatment discontinuation criteria were met. After the end of study treatment in both treatment groups, patients will continue to receive adjuvant hormone therapy for a total of at least 5 years and up to a maximum of 10 years if medically appropriate (2 years in the study followed by a further 3 years). 8 years in long-term follow-up).

The safety profile of abemaciclib in HR +, HER2- in early breast cancer was consistent with the known safety profile of this drug in advanced breast cancer. There were no new, previously unknown adverse events ^1,2 .

Breast cancer is the most common cancer that affects women worldwide ³ . Although the prognosis for early HR +, HER2- breast cancer is generally positive, 20-30% of patients can develop terminal ⁴ metastatic disease. The risk of recurrence is highest in the first years after diagnosis, especially in patients with early breast cancer at high risk of recurrence, with nodal metastases ⁵ .

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References:

^[1] 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.

² SABCS 2020 PO Presentation: O’Shaughnessy JA, Johnston S, Harbeck N, et al. Primary outcome analysis of invasive disease-free survival for monarchE: Abemaciclib combined with adjuvant endocrine therapy for high risk early breast cancer. Oral presentation at: San Antonio Breast Cancer Symposium; December, 2020: San Antonio, TX.

³ World Health Organization. Breast cancer: prevention and control. https://www.who.int/cancer/detection/breastcancer/en/index1.html . Accessed: September 8, 2020.

⁴ 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 randomized trials. Lancet . 2005; 365 (9472): 1687-1717. doi: 10.1016/S0140-6736 (05) 66544-0.

⁵ 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.