For heavily pretreated women with HR+, HER2– MBC
Verzenio achieved an ORR of almost 20% as a single agent1-5*
Median duration of response (mDoR)5§
- 3.7-month median time to response (range: 1.1-14.2 months)5,7
- 7.2-month mDoR (95% CI: 5.6-NR) per independent review1
‡ORR was defined as the proportion of patients with CR + PR and does not include stable disease.1,8 PR defined as ≥30% reduction in target lesion size per RECIST 1.1.5,8
§Among 26 patients (investigator assessed) and 23 patients (independent review) who had a PR.1
Verzenio is the only CDK4 & 6 inhibitor to receive single-agent approval1
MONARCH 1: Phase II, single-arm trial in women with HR+, HER2- MBC1,5
MONARCH 1 was a single-arm, open-label, multicenter study in 132 women with measurable HR+, HER2- metastatic breast cancer whose disease progressed during or after endocrine therapy, had received a taxane in any setting, and who received 1 or 2 prior chemotherapy regimens in the metastatic setting. Patients had an Eastern Cooperative Oncology Group Performance Status of 0 (55% of patients) or 1 (45% of patients). Patients took 200 mg of Verzenio orally, twice daily, on a continuous schedule, unless disease progression or unacceptable toxicity occurred. The primary endpoint was ORR. A key secondary endpoint was DoR.
- Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.
- Imkampe A, Bendall S, Bates T. The significance of the site of recurrence to subsequent breast cancer survival. Eur J Surg Oncol. 2007;33:420-423.
- Largillier R, Ferrero JM, Doyen J, et al. Prognostic factors in 1038 women with metastatic breast cancer. Ann Oncol. 2008;19:2012-2019.
- Solomayer EF, Diel IJ, Meyberg GC, Gollan C, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat. 2000;59:271-278.
- Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2– metastatic breast cancer. Clin Cancer Res. 2017;23:5218-5224.
- Data on file. Lilly USA, LLC. ONC20170111b.
- Data on file. Lilly USA, LLC. ONC20171201a.
- Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-247.