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Verzenios ® (abemaciclib)
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What information is available regarding venous thromboembolic events with Verzenios® (abemaciclib) in metastatic or advanced breast cancer?
VTEs with abemaciclib were reported in 5% and 6% of patients in the abemaciclib arms in MONARCH 2 and MONARCH 3, respectively.
What information is available regarding venous thromboembolic events with abemaciclib in metastatic or advanced breast cancer?
Phase 3 Clinical Trial Program
In patients receiving abemaciclib plus fulvestrant or aromatase inhibitors, venous thromboembolic events (VTEs) have been reported. These include
- 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.
Event, n (%) |
MONARCH 2 |
MONARCH 3 |
||
Abemaciclib + Fulvestrant |
Placebo + Fulvestrant |
Abemaciclib + NSAI |
Placebo + NSAI |
|
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.
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
Date of Last Review: 15 October 2024