Verzenios ® ▼ (abemaciclib)

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Are Verzenios® ▼ (abemaciclib) patients at an increased risk of experiencing venous thromboembolic events?

VTEs with abemaciclib were reported in 3%, 5%, and 6% of patients in the abemaciclib arms in MONARCH 1, MONARCH 2 and MONARCH 3, respectively. In nextMONARCH 1, VTEs were reported in 3.9% to 9% of patients, depending on the treatment arm.

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UK_cFAQ_ABE045_VTE_MBC
en-GB

Detailed Information

Venous thromboembolic events (VTEs) occurred in more patients who took abemaciclib than in patients who received placebo in the phase 3 studies for metastatic breast cancer.

What information is available regarding venous thromboembolic events with abemaciclib in metastatic or advanced breast cancer?

Phase 3 Clinical Trial Program 

VTEs have been identified as an adverse drug reaction for abemaciclib. This includes

  • deep vein thrombosis
  • pulmonary embolism
  • pelvic venous thrombosis
  • cerebral venous sinus thrombosis
  • subclavian and axillary vein thrombosis, and
  • inferior vena cava thrombosis.

Across the clinical development program, deaths due to VTEs have been reported.1

Most events were

  • considered non-serious
  • treated with low molecular weight heparin, and
  • not resulting in discontinuation of abemaciclib.

Risk factors for VTEs were balanced between study arms and overall, there were no specific risk factors identified that could predict VTEs with abemaciclib treatment.1

VTEs in MONARCH 2 and 3 are described further in VTEs in MONARCH 2 and MONARCH 3.

VTEs in MONARCH 2 and MONARCH 32

Event, n (%)

MONARCH 2

MONARCH 3

Abemaciclib + Fulvestrant
(N=441)

Placebo + Fulvestrant
(N=223)

Abemaciclib + NSAI
(N=327)

Placebo + NSAI
(N=161)

VTE (all grade)

21 (4.8)

2 (0.9)

20 (6.1)

1 (0.6)

PE

11 (2.5)

0

11 (3.4)a

1 (0.6)

DVT

10 (2.3)

2 (0.9)

9 (2.8)

0

Grade ≥3

9 (2.0)

1 (0.4)

10 (3.1)

1 (0.6)

Death

0

0

3 (0.9)

0

SAE

8 (1.8)

1 (0.4)

9 (2.8)

1 (0.6)

PE

4 (0.9)

0

7 (2.1)b

1 (0.6)

DVT

4 (0.9)

1 (0.4)

4 (1.2)b

0

Discontinuation

2 (0.5)

0

4 (1.2)c

0

Dose reduction

2 (0.5)

0

0

1 (0.6)

Abbreviations: DVT = deep vein thrombosis; NSAI = nonsteroidal aromatase inhibitor; PE = pulmonary embolism; SAE = serious adverse event; VTE(s) = venous thromboembolic event(s).

aThree patients experienced both PE and DVT.

bTwo patients with an SAE experienced both a PE and a DVT.

cIncludes 3 patients who died.

In MONARCH 1, 4 patients (3.0%) experienced VTEs, two of which were grade >3. No VTEs resulted in treatment discontinuation or dose reductions.3

nextMONARCH 1

The nextMONARCH 1 study was a phase 2, randomized, open-label trial of abemaciclib with or without tamoxifen in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer who progressed on prior endocrine therapy and chemotherapy.4-6

Patients were stratified by presence or absence of liver metastases at baseline and prior use of tamoxifen in the advanced/metastatic setting and randomized 1:1:1 to

  • A + T: abemaciclib 150 mg every 12 hours plus tamoxifen 20 mg every day
  • A-150: abemaciclib 150 mg every 12 hours as monotherapy, or
  • A-200: abemaciclib 200 mg every 12 hours plus prophylactic loperamide.6

Prophylactic loperamide 2 mg daily was administered with the first dose of abemaciclib during cycle 1 and then either prophylactically or at the investigator's discretion during subsequent cycles.6

The incidence of venous thromboembolisms was

  • 7 (9.0%) in A + T
  • 4 (5.1%) in A-150, and
  • 3 (3.9%) in A-200.6

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Rugo HS, Huober J, Garcia-Saenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist. 2021;26(1):e53-e65. http://dx.doi.org/10.1002/onco.13531

3Rugo HS, Huober J, Llombart-Cussac A, et al. Management of abemaciclib associated adverse events in patients with HR+, HER2- advanced breast cancer: analysis of the MONARCH trials. Poster presented at: Annual Meeting of the European Society for Medical Oncology (ESMO) European Cancer Congress (ECC); October 19-23, 2018; Munich, Germany. Accessed October 21, 2021. https://www.lillymedical.com/en-us/answers/management-of-abemaciclib-associated-adverse-events-in-patients-with-hr-her2-advanced-breast-cancer-analysis-of-the-monarch-trials-88694?hcpToken=A12DSa08bhrd123gg8

4A study of abemaciclib (LY2835219) plus tamoxifen or abemaciclib alone in women with metastatic breast cancer (next MONARCH 1). ClinicalTrials.gov Identifier: NCT02747004. Updated August 19, 2021. Accessed February 24, 2022. https://clinicaltrials.gov/show/NCT02747004

5Hamilton E, Cortes J, Dieras V, et al. nextMONARCH 1: phase 2 study of abemaciclib plus tamoxifen or abemaciclib alone in HR+, HER2- advanced breast cancer. Cancer Res. 2019;79(4 suppl):PD1-11. American Association for Cancer Research abstract PD1-11. https://doi.org/10.1158/1538-7445.SABCS18-PD1-11

6Hamilton E, Cortes J, Ozyilkan O, et al. nextMONARCH: abemaciclib monotherapy or combined with tamoxifen for metastatic breast cancer. Clin Breast Cancer. 2021;21(3):181-190.e2. https://doi.org/10.1016/j.clbc.2020.09.011

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: 05 January 2022


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