Verzenio® (Abemaciclib)

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Abemaciclib: MONARCH 3 - Use With NSAI in ABC

Abemaciclib demonstrates efficacy in combination with an NSAI with a PFS of 28.2 months in the abemaciclib arm vs 14.8 months in the placebo arm.


The information contained in this letter may not completely match the current local labeling for ABEMACICLIB. Please see local labeling approved in your country. 


MONARCH 3 was a randomized, double-blind, placebo-controlled, phase 3 study of abemaciclib or placebo with an NSAI (anastrozole or letrozole) in 493 postmenopausal women with HR+, HER2- advanced or MBC with no prior systemic treatment in this setting.1

Endocrine therapy in the neoadjuvant or adjuvant setting was permitted if patients had a disease free interval of >12 months since completion of ET.1

Patients were randomized 2:1 to abemaciclib or placebo in combination with an NSAI.

  • Abemaciclib 150 mg or matching placebo was administered orally twice daily on a continuous schedule.
  • Anastrozole 1 mg or letrozole 2.5 mg (per physician’s choice) was administered orally once daily on a continuous schedule.1

Patients were stratified according to metastatic site (visceral, bone-only, vs other) and prior (neo)adjuvant ET (AI, no ET, vs other). The primary endpoint was investigator-assessed PFS and key secondary endpoints included OS, response rates, and safety.1


Progression-free survival was evaluated according to RECIST version 1.1. At the time of the final PFS analysis, median follow-up was 26.7 months and OS data were immature.1,2 Median relative dose intensity was 85% for abemaciclib and 98% for placebo.2

Primary and Select Secondary Efficacy Endpoints in MONARCH 32


Abemaciclib + NSAI

Placebo + NSAI

Progression-free survivala



Median, months



Hazard ratio (95% CI)

0.540 (0.418, 0.698)

P value


Duration of responseb



Median, months



Best overall response for ITT population



Objective response rate, %c



Complete response, %



Clinical benefit rate, %d



Best overall response for patients With measurable disease



Objective response rate, %c



Complete response, %



Clinical benefit rate, %d



Abbreviations: ITT = intent-to-treat; NSAI = nonsteroidal aromatase inhibitor.


bResponder population.

cObjective response rate = complete response + partial response.

dClinical benefit rate = complete response + partial response + stable disease ≥6 months.

eConfirmed objective response rate = 55.4%.

fConfirmed objective response rate = 40.2%.

A blinded independent central review was conducted and confirmed ITT PFS benefit (HR=0.465; 95% CI: 0.339-0.636; p<.000001).2

Abemaciclib plus an NSAI demonstrated improved PFS across all patient subgroups analyzed.1-3

While all subpopulations benefited from the addition of abemaciclib to ET regardless of prognosis, in a subgroup analysis of patients in MONARCH 2 and MONARCH 3, substantial benefit of abemaciclib (characterized by large increases in PFS [HRs=0.4-0.5] and ORR [>30%]) was observed in poor prognosis subgroups with liver metastases, PR- tumors, and high-grade tumors.3

A subpopulation treatment effect pattern plot analysis of TFI of the MONARCH 3 patients who had received adjuvant ET demonstrated that patients who had a shorter TFI had a worse prognosis and received relatively greater benefit from abemaciclib plus NSAI than did patients with a longer TFI. Patients with bone-only disease or a longer TFI also received benefit from abemaciclib, but to a relatively lesser extent (HR ranging from approximately 0.6-0.8).3


Adverse Reactions in the MONARCH 3 Safety Population (abemaciclib+NSAI, n=327; placebo+NSAI, n=161)4

All grade adverse reactions reported in ≥20% of patients

Grade 3 or 4 adverse reactions reported in ≥5% of patients

  • diarrhea
  • neutropenia
  • nausea
  • infections
  • abdominal pain
  • fatigue
  • anemia
  • vomiting
  • alopecia
  • decreased appetite
  • leukopenia
  • neutropenia
  • alanine aminotransferase increased
  • diarrhea
  • leukopenia
  • anemia

Abbreviation: NSAI = nonsteroidal aromatase inhibitor.

In the abemaciclib arm, 13% of patients permanently discontinued treatment and dose reductions occurred in 43% of patients due to adverse reactions.5

Deaths due to AEs were reported in 11 patients in the abemaciclib arm and included

  • lung infection (n=4)
  • embolism (n=2)
  • respiratory failure (n=2)
  • cerebral ischemia (n=1)
  • cerebrovascular accident (n=1), and
  • pneumonitis (n=1).1,2

Deaths due to AEs were reported in 2 patients in the placebo arm and included

  • general physical health deterioration (n=1), and
  • sudden death (n=1).1,2


Abemaciclib plus NSAI significantly improved PFS and ORR as initial therapy for HR+, HER2- postmenopausal advanced breast cancer patients compared with NSAI alone. Abemaciclib was generally well tolerated.1,2


1Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646.

2Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5.

3Di Leo A, O'Shaughnessy J, Sledge GW Jr, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41.

4Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.


AE = adverse event

ALT = alanine aminotransferase 

ET = endocrine therapy

HER2- = human epidermal growth factor receptor 2-negative

HR = hazard ratio

HR+ = hormone receptor-positive

ITT = intent-to-treat

MBC = metastatic breast cancer

NSAI = nonsteroidal aromatase inhibitor

ORR = overall response rate

OS = overall survival

PFS = progression-free survival

RECIST = Response Evaluation Criteria in Solid Tumors

TFI = treatment-free interval

Fecha de la última revisión: 2019 M03 13

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