Verzenio® (Abemaciclib)

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Abemaciclib: MONARCH 1 - Single Agent Use in MBC

In a phase 2 trial, abemaciclib demonstrated single agent activity in patients with HR+, HER2- MBC.

MX_cFAQ_ABE029_MONARCH_1_SINGLE_AGENT
MX_cFAQ_ABE029_MONARCH_1_SINGLE_AGENT
es-MX

Detailed Information

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 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 chemotherapy.1 

Abemaciclib 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

A 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 disease.2 Prior therapies in the metastatic setting included

  • ET (87.1%)
  • fulvestrant (50.8%)
  • taxane (68.9%)
  • everolimus (28.0%), and
  • capecitabine (55.3%).1,3

In the MONARCH 1 trial, exposure measurements included 

  • patients who received ≥8 cycles of therapy (35.6%)
  • median dose compliance (99%), and
  • median relative dose intensity (89.2%).1,2,4

The 12-month primary analysis is presented in MONARCH 1 Primary 12-Month Efficacy Analysis Results.

MONARCH 1 Primary 12-Month Efficacy Analysis Results1

Endpoint

Abemaciclib Monotherapy
N=132

Objective response rate (CR+PR)

19.7%

CR

0%

PR

19.7%

Disease control rate (CR+PR+SD)

67.4%

Clinical benefit rate (CR+PR+SD >6 months)

42.4%

Median progression-free survival

6.0 months

Median overall survival

17.7 months

Median time to response

3.7 months

Median duration of treatment response

8.6 months

Abbreviations: CR = complete response; PR = partial response; SD = stable disease.

The most common adverse reactions, occurring in ≥20% of patients were

  • diarrhea
  • fatigue
  • nausea
  • abdominal pain
  • infections
  • decreased appetite
  • vomiting
  • neutropenia
  • anemia
  • thrombocytopenia, and
  • headache.5

Dose reductions due to adverse reactions were reported in 49% of patients. Overall, discontinuation of abemaciclib due to adverse reactions was 8%.4

Diarrhea was reported in 90.2% of patients overall (median onset of 7 days) as

  • grade 2: 28.8% of patients
  • grade 3: 19.7% of patients, and
  • grade 4: no patients.

One patient discontinued treatment due to diarrhea. The majority of patients responded to management with over the counter antidiarrheal medications and dose alterations.1

Neutropenia as an AR was observed in 37.1% of patients overall as

  • grade 3: 18.9% of patients, and
  • grade 4: 5.3% of patients.

One 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

Creatinine laboratory values were increased in 98.5% of patients.1

Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters without affecting glomerular function.4

References

1Dickler 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(17):5218-5224. http://dx.doi.org/10.1158/1078-0432.CCR-17-0754

2Dickler 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. http://abstract.asco.org/176/AbstView_176_164546.html

3Rugo 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 Virtual); April 1-5, 2017. Accessed April 13, 2021. http://webcast.aacr.org/s/2017annual/CTSY03;jsessionid=37972ACCE273164EDABF5110831422D6

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

AR = adverse reaction

ET = endocrine therapy

HER2- = human epidermal growth factor receptor 2-negative

HR+ = hormone receptor-positive

MBC = metastatic breast cancer

ORR = objective response rate

Fecha de la última revisión: 2020 M01 27


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