Therapeutic Response

ER positive, HER2-negative, and PR positive status confers therapeutic sensitivity to Abemaciclib in combination with Tamoxifen in patients with Invasive Breast Carcinoma.

Statements

Source and description
Verzenio (abemaciclib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).
Verzenios (abemaciclib) [product information]. EMA. The European Medicines Agency (EMA) has authorized 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. Abemaciclib's product information further states that in pre- or perimenopausal women, aromatase inhibitor endrocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. The product information further states that this indication was approved based on results from the monarchE study, a randomized, open label, two cohort, phase 3 study which enrolled a total of 5,637 patients who were randomized in a 1:1 ratio to receive 2 years of abemaciclib plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).