Verzenios ® (abemaciklib)

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Verzenios® ▼ (abemaciclib): Venösa tromboemboliska händelser

Venösa tromboemboliska händelser med abemaciclib rapporterades hos 5% och 6% av patienterna i abemaciclibarmarna i MONARCH 2 respektive MONARCH 3.

Detailed Information

In the abemaciclib phase 3 clinical trial program for breast cancer, VTEs have been identified as an adverse drug reaction for abemaciclib. VTEs included DVT, PE, 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

Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate.2

There were a greater number of patients who experienced VTEs in the abemaciclib arms than the placebo arms in the abemaciclib randomized phase 3 studies (MONARCH 2 and MONARCH 3). The majority of events were nonserious and were treated with low molecular weight heparin. Generally these events did not result in discontinuation of the study drug. 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

The breakdown of VTEs in the phase 3 studies is presented in Table 1.

Table 1. VTEs in MONARCH 2 and MONARCH 31,3

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 (3.0)

1 (0.6)

Death

0

0

3 (0.9)b

0

SAE

8 (1.8)c

1 (0.4)

9 (2.8)

1 (0.6)

DC (all events)

2 (0.5)

0

4 (1.2)d

0

Dose reduction

2 (0.5)

0

0

1 (0.6)

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

a Three patients experienced both PE and DVT.

b PE and DVT; Thromboembolism not further investigated; Respiratory failure.

c 4 PE and 4 DVT.

d Includes 3 patients who died.

In MONARCH 1, 4 patients (3.0%) experienced VTEs.3

nextMONARCH 1

nextMONARCH 1 was a phase 2, randomized, open-label trial of abemaciclib with or without tamoxifen in women with HR+, HER2- advanced or MBC who progressed on prior ET and chemotherapy.4,5

Patients were stratified by liver metastases and prior use of tamoxifen in the advanced setting and randomized 1:1:1 to

  • arm A: abemaciclib 150 mg every 12 hours plus tamoxifen 20 mg every day 

  • arm B: abemaciclib 150 mg every 12 hours as monotherapy, or

  • arm C: abemaciclib 200 mg every 12 hours plus prophylactic loperamide.5

Prophylactic loperamide 2 mg daily was administered during cycle 1 and then at the investigator's discretion.5

The incidence of VTEs was

  • 7 (9.0%) in arm A

  • 4 (5.1%) in arm B, and

  • 3 (3.9%) in arm C.5

References

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

2. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3. Rugo 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. https://www.esmo.org/content/download/149891/2691140/file/EMSO-2018-Abstract-Book-partial-version.pdf

4. A study of abemaciclib (LY2835219) plus tamoxifen or abemaciclib alone in women with metastatic breast cancer (nextMONARCH 1). ClinicalTrials.gov website. https://clinicaltrials.gov/show/NCT02747004. Updated July 12, 2019. Accessed January 28, 2020.

5. Hamilton E, Cortés J, Diéras V, et al. nextMONARCH 1: phase 2 study of abemaciclib plus tamoxifen or abemaciclib alone in HR+, HER2- advanced breast cancer. Poster presented at: 41st Annual San Antonio Breast Cancer Symposium (SABCS); December 4-8, 2018; San Antonio, TX. http://sabcs18.posterview.com/nosl/i/PD1-11

Glossary

DVT = deep vein thrombosis

ET = endocrine therapy

HER2- = human epidermal growth factor receptor 2-negative

HR+ = hormone receptor-positive

MBC = metastatic breast cancer

PE = pulmonary embolism

VTE = venous thromboembolic event

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.

Datum fӧr senaste ӧversyn 2020 M01 28

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