Verzenio® (Abemaciclib)

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Abemaciclib: MONARCH 2 and MONARCH 3 Subgroup Manuscript

In a subgroup analysis of patients in MONARCH 2 and MONARCH 3, substantial benefit of abemaciclib was observed in poor prognosis subgroups.


The information contained in this letter may not completely match the current local labeling for ABEMACICLIB. Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.

Detailed Information

A combined exploratory analysis of MONARCH 2 and MONARCH 3 was conducted in women with HR+, HER2- ABC to determine significant prognostic factors and to examine patient and disease characteristics that may inform in whom and when abemaciclib should be initiated.1

  • In MONARCH 2, patients whose disease had progressed while receiving ET were administered fulvestrant + abemaciclib/placebo.2
  • In MONARCH 3, patients received a NSAI + abemaciclib/placebo as initial therapy for advanced disease.3

While all subpopulations benefited from the addition of abemaciclib to ET regardless of prognosis, 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, progesterone receptor-negative tumors, and high-grade tumors.1

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 (<36 months) had a worse prognosis and received relatively greater benefit from abemaciclib plus NSAI than did patients with a longer TFI (>or= 36 months).1


1Di Leo A, O'Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy [published online December 18, 2018]. NPJ Breast Cancer. 2018;4(1):41.

2Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884.

3Johnston 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.


ABC = advanced breast cancer

ET = endocrine therapy

HER2- = human epidermal growth factor receptor 2-negative

HR = hazard ratio

HR+ = hormone receptor-positive

NSAI = nonsteroidal aromatase inhibitor

ORR = objective response rate

PFS = progression-free survival

TFI = treatment-free interval

Fecha de la última revisión: 2019 M06 25

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