Abemaciclib in Breast Cancer

Target Development Name Generic Name Trade Name Status
CDK4/6 LY2835219 abemaciclib   Trials completed with resultsa

 

a In a phase 1 trial with several expansion cohorts, abemaciclib showed activity in several tumor types, including lung cancer and breast cancer, in preliminary reports. In an ER-positive metastatic breast cancer cohort, 36 patients treated with the combination of abemaciclib and fulvestrant demonstrated a clinical benefit rate of 81% (Table 1; Goldman et al. 2014; Patnaik et al. 2014a, 2014b; Shapiro et al. 2013).

Table 1. Reported Trial with Abemaciclib in Breast Cancer.

Reference Study Type / Phase Therapeutic setting Treatment Agent Mutation Status / Group # Pts in Study RR PFS (months) OS (months)
Patnaik et al. 2014a, 2014b Phase 1 Metastatic breast cancer abemaciclib HR+ 36 25%    
abemaciclib + fulvestrant (expanded cohort) HR+ 13 62%    

NOTE: CR = complete response; ER = estrogen receptor; HR = hormone receptor (ER and/or PR); OS = overall survival; PFS = progression-free survival; PR = partial response; PR = progesterone receptor; Pts = patients; RR = response rate (CR + PR).

Table 2. Ongoing and Recruiting Clinical Investigation with Abemaciclib in Breast Cancer.

Study Type / Phase / ID Therapeutic setting Prior therapy requirement Treatment Agent Mutation Status/Group # Patients in Study Study Start Date
Phase 1 (NCT02057133) 1st line, locally advanced or metastatic breast cancer, pre- or postmenopausal No prior prior systemic endocrine therapy abemaciclib + letrozole ER+ and/or PR+
HER2–
81 March 2014
1st line, locally advanced or metastatic breast cancer, pre- or postmenopausal No prior prior systemic endocrine therapy abemaciclib + anastrozole
1st line or greater, locally advanced or metastatic breast cancer, pre- or postmenopausal   abemaciclib + tamoxifen
2nd line or greater, locally advanced or metastatic breast cancer, pre- or postmenopausal Prior therapy with anastrozole or letrozole required abemaciclib+ exemestane
2nd line or greater, locally advanced or metastatic breast cancer, pre- or postmenopausal Prior therapy with anastrozole or letrozole required abemaciclib + exemestane + everolimus
Phase 2 (MONARCH 1, NCT02102490) 1st line or greater, locally advanced or metastatic breast cancer Disease progression after anti-estrogen therapy and 2 prior chemotherapy regimens required abemaciclib ER+ and/or PR+
HER2–
128 June 2014
Phase 3 (MONARCH 2, NCT02107703) 1st or 2nd line, locally advanced or metastatic breast cancer, postmenopausal Either no prior endocrine therapy or progression during or within 12 months of adjuvant endocrine therapy or greater than 12 months and progressed after first-line endocrine therapy for metastatic disease, or progression after first-line therapy (no adjuvant therapy) abemaciclib + fulvestrant ER+ and/or PR+
HER2–
550 July 2014
placebo + fulvestrant
Phase 3 (MONARCH 3, NCT02246621) 1st line or greater, locally advanced or metastatic breast cancer, postmenopausal   abemaciclib + anastrozole or letrozole ER+ and/or PR+
HER2–
450 October 2014, not yet recruiting
anastrozole or letrozole + placebo

NOTE: ER = estrogen receptor; HER2 = human epidermal growth factor receptor 2; PR = progesterone receptor.

Contributors: Justin M. Balko, Pharm. D., Ph.D., Ingrid A. Mayer, M.D., M.S.C.I., Mia Levy, M.D., Ph.D., Carlos L. Arteaga, M.D.

Suggested Citation: Balko, J., I. Mayer, M. Levy, C. Arteaga. 2015. Abemaciclib in Breast Cancer. My Cancer Genome http://www.padiracinnovation.org/content/molecular-medicine/abemaciclib-in-breast-cancer/ (Updated June 17).

Last Updated: June 22, 2015

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