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.mycancergenome.org/content/molecular-medicine/abemaciclib-in-breast-cancer/ (Updated June 17).
Last Updated: June 22, 2015