1 was a phase 2, single-arm study which evaluated safety and efficacy
of abemaciclib as monotherapy in 132 women with refractory HR+, HER2-
advanced or MBC whose disease progressed on or after both ET and
200 mg was administered orally every 12 hours on a continuous
schedule (days 1-28 of a 28-day cycle) until disease progression or
unacceptable toxicity. The primary objective of MONARCH 1 was to
evaluate investigator-assessed ORR performed at 12 months after the
last patient had entered treatment.1
total of 132 women were treated with abemaciclib monotherapy. All
patients had a median of 5 lines of prior therapy for any setting,
including a median of 3 lines of prior therapy for metastatic
Prior therapies in the metastatic setting included
the MONARCH 1 trial, exposure measurements included
who received ≥8 cycles of therapy (35.6%)
dose compliance (99%), and
relative dose intensity (89.2%).1,2,4
12-month primary analysis is presented in Table
1. MONARCH 1 Primary 12-Month Efficacy Analysis Results1
response rate (CR+PR)
control rate (CR+PR+SD)
benefit rate (CR+PR+SD >6 months)
time to response
duration of treatment response
CR = complete response; PR = partial response; SD = stable disease.
most common adverse reactions, occurring in ≥20% of patients were
reductions due to adverse reactions were reported in 49% of patients.
Overall, discontinuation of abemaciclib due to adverse reactions was
was reported in 90.2% of patients overall (median onset of 7 days) as
2: 28.8% of patients
3: 19.7% of patients, and
4: no patients.
patient discontinued treatment due to diarrhea. The majority of
patients responded to management with over the counter antidiarrheal
medications and dose alterations.1
as an AR was observed in 37.1% of patients overall as
3: 18.9% of patients, and
4: 5.3% of patients.
patient experienced febrile neutropenia which occurred during the
study follow-up period (19 days after discontinuation of abemaciclib)
and 8 days after the patient began cytotoxic chemotherapy
(fluorouracil and vinorelbine).1
laboratory values were increased in 98.5% of patients.1
has been shown to increase serum creatinine due to inhibition of
renal tubular secretion transporters without affecting glomerular
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
[published correction appears in Clin Cancer Res.
]. Clin Cancer Res. 2017;23(17):5218-5224.
Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1: results from a
phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as
monotherapy, in patients with HR+/HER2- breast cancer, after
chemotherapy for advanced disease. Presented as an oral presentation
at: 52nd Annual Meeting of the American Society of Clinical Oncology
(ASCO); June 03-07, 2016; Chicago, IL.
Rugo HS, Tolaney SM, Cortés J, et al. MONARCH 1: Final
overall survival analysis of a phase 2 study of abemaciclib, a CDK4
and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast
cancer, after chemotherapy for advanced disease. Talk presented at:
108th Annual Meeting of the American Association for Cancer Research
(AACR); April 1-5, 2017; Washington, DC.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company;
= human epidermal growth factor receptor 2-negative
= hormone receptor-positive
= metastatic breast cancer
= objective response rate