Therapeutic Response

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

Statements

Source and description
Abemaciclib Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved abemaciclib in combination with endocrine therapy for reimbursement as a treatment option for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence in adult patients. According to the European Medicine Agency's product information for abemaciclib, 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%).
Verzenio (abemaciclib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on the MONARCH 3 (NCT02246621) clinical trial, which was a randomized (2:1), double-blinded, placebo-controlled, multicenter study. A total of 493 patients were randomized to receive 150 mg abemaciclib or placebo orally twice daily, plus physician's choice of letrozole (80% of patients) or anastrozole (20%).
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 and an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy, or in women who have received prior endocrine therapy, for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Abemaciclib's product information further states that in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. This indication is based on the randomized, double-blind, placebo-controlled phase 3 study MONARCH 3 that used either anastrozole or letrozole as an aromatase inhibitor.
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%).