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Verzenios ® (abemaciclib)
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What are the common side effects of Verzenios® (abemaciclib) in metastatic breast cancer?
The most common adverse reactions for abemaciclib were diarrhea, fatigue, neutropenia, and nausea.
Detailed information
Abemaciclib in combination with nonsteroidal aromatase inhibitor (NSAI) in MONARCH 3
Adverse reactions in MONARCH 3 are presented in Adverse Reactions in the MONARCH 3 Safety Population (abemaciclib+anastrozole or letrozole, n=327; placebo+anastrozole or letrozole, n=161). Serious adverse events were reported in 27.5% of patients in the abemaciclib plus anastrozole or letrozole arm, compared to 14.9% of patients in the placebo arm.1
The most frequently reported serious adverse event was lung infection, which occurred in 2.8% of patients in the abemaciclib arm and zero in the placebo arm.1
All grade adverse reactions reported (≥20%) in the abemaciclib arm and ≥2% than the placebo arm |
Grade 3 or 4 adverse reactions reported in ≥5% of patients |
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Abbreviation: ALT = alanine aminotransferase.
Deaths were reported in 15 patients in the abemaciclib arm, 11 of which were due to adverse events (AEs). Deaths due to AEs included
- lung infection (n=4)
- embolism (n=2)
- respiratory failure (n=2)
- cerebral ischemia (n=1)
- cerebrovascular accident (n=1), and
- pneumonitis (n=1).3
Deaths were reported in 3 patients in the placebo arm, 2 of which were due to AEs. Deaths due to AEs included
- general physical health deterioration (n=1), and
- sudden death (n=1).3
Abemaciclib in combination with Fulvestrant in MONARCH 2
Adverse reactions in MONARCH 2 are presented in Adverse Reactions in the MONARCH 2 Safety Population (abemaciclib+fulvestrant, n=441; placebo+fulvestrant, n=223). Serious adverse events were reported in 22% of patients in the abemaciclib arm and 11% of patients in the placebo arm.4
All grade adverse reactions reported (≥20%) in the abemaciclib arm and ≥2% than the placebo arm |
Grade 3 or 4 adverse reactions reported in ≥5% of patients |
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Deaths during treatment or during the 30-day follow-up were reported in
- 18 patients (4%) in the abemaciclib arm, and
- 10 patients (5%) in the placebo arm.5
Deaths due to AEs were reported in
- 9 patients in the abemaciclib arm, and
- 2 patients in the placebo arm.4
Deaths deemed by the investigators to be related to abemaciclib treatment were reported in
- 2 patients with sepsis in whom guidance regarding granulocyte colony stimulating factor administration and dose reduction was not followed, and
- 1 patient with viral pneumonia receiving steroids for spinal stenosis.4
Of the 18 reported deaths in patients in the abemaciclib plus fulvestrant arm, 2 (0.5%) were due to pneumonitis.5
Diarrhoea
Diarrhea typically occurred early, and was managed with abemaciclib dose adjustment and antidiarrheal medication. Patients were instructed to initiate antidiarrheal agents at the first sign of loose stools and increase intake of oral fluids. If grade ≤1 was not reached within 24 hours, treatment was temporarily discontinued until diarrhea resolved to grade <1. Dose reductions, omissions, and modifications occurred for grade ≥3 or persistent grade 2 diarrhea.6,7
Increases in serum creatinine
References
1Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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. https://doi.org/10.1038/s41523-018-0097-z
4Sledge GW Jr, 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. https://doi.org/10.1200/JCO.2017.73.7585
5Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
6Rugo 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
7Rugo 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
8Tolaney S, Lam AQ, Mukundan S, et al. Analysis of renal function in MONARCH 1: A phase 2 study of abemaciclib, a CDK4 & 6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for metastatic breast cancer (MBC). Cancer Res. 2017;77(4 suppl):P6-15-01. American Association for Cancer Research abstract P6-15-01. http://cancerres.aacrjournals.org/content/77/4_Supplement/P6-15-01
Date of Last Review: 28 February 2024