Verzenio® (Abemaciclib)

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Abemaciclib: Most Frequent Adverse Drug Reactions

The most common adverse reactions for abemaciclib were diarrhea, fatigue, neutropenia, and nausea.

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Detailed Information

Abemaciclib in Combination With a Nonsteroidal Aromatase Inhibitor (MONARCH 3)

Adverse reactions in MONARCH 3 are presented in Adverse Reactions in the MONARCH 3 Safety Population (abemaciclib+NSAI, n=327; placebo+NSAI, n=161). Serious adverse events were reported in 31% of patients in the abemaciclib arm and 17% of patients in the placebo arm.1

Adverse Reactions in the MONARCH 3 Safety Population (abemaciclib+NSAI, n=327; placebo+NSAI, n=161)2

All grade adverse reactions reported in ≥20% of patients

Grade 3 or 4 adverse reactions reported in ≥5% of patients

  • diarrhea
  • neutropenia
  • nausea
  • infections
  • abdominal pain
  • fatigue
  • anemia
  • vomiting
  • alopecia
  • decreased appetite
  • leukopenia
  • neutropenia
  • alanine aminotransferase increased
  • diarrhea
  • leukopenia
  • anemia

Abbreviation: NSAI = nonsteroidal aromatase inhibitor.

Deaths due to AEs were reported in 11 patients in the abemaciclib arm and included

  • lung infection (n=4)
  • embolism (n=2)
  • respiratory failure (n=2)
  • cerebral ischemia (n=1)
  • cerebrovascular accident (n=1), and
  • pneumonitis (n=1).3,4

Deaths due to AEs were reported in 2 patients in the placebo arm and included

  • general physical health deterioration (n=1), and
  • sudden death (n=1).3,4

Abemaciclib in Combination With Fulvestrant (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.5

Adverse Reactions in the MONARCH 2 Safety Population (abemaciclib+fulvestrant, n=441; placebo+fulvestrant, n=223)2

All grade adverse reactions reported in ≥20% of patients

Grade 3 or 4 adverse reactions reported in ≥5% of patients 

  • diarrhea
  • fatigue
  • neutropenia
  • nausea
  • infections
  • abdominal pain
  • anemia
  • leukopenia
  • decreased appetite
  • vomiting
  • headache
  • neutropenia
  • diarrhea
  • leukopenia
  • anemia
  • infections

Deaths during treatment or during the 30-day follow-up were reported in

  • 14 patients (3%) 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.5

Deaths deemed by the investigators to be related to abemaciclib treatment were reported in

  • 2 patients with sepsis in whom guidance regarding GCSFs administration and dose reduction was not followed, and
  • 1 patient with viral pneumonia receiving steroids for spinal stenosis.5

Additionally, 2 deaths (0.5%) due to pneumonitis were reported in patients receiving abemaciclib plus fulvestrant.2

Abemaciclib Administered as a Single Agent (MONARCH 1)

Adverse reactions in MONARCH 1 are presented in Adverse Reactions in the MONARCH 1 Safety Population (abemaciclib monotherapy, n=132). Serious adverse events occurred in 32 patients (24.2%) in the study.6

Adverse Reactions in the MONARCH 1 Safety Population (abemaciclib monotherapy, n=132)2

All grade adverse reactions reported in ≥20% of patients  

Grade 3 or 4 adverse reactions reported in ≥5% of patients 

  • diarrhea
  • fatigue
  • nausea
  • decreased appetite
  • abdominal pain
  • neutropenia
  • vomiting
  • infections
  • anemia
  • headache
  • thrombocytopenia
  • diarrhea
  • nausea
  • infections
  • fatigue
  • neutropenia
  • anemia
  • leukopenia

Deaths on abemaciclib therapy were reported for 2 patients (1.5%), including 1 patient who died due to a TEAE of sepsis and 1 patient who died due to a TEAE of pneumonitis.1

Increases in Serum Creatinine

Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters, without affecting glomerular function.1,7

Diarrhea

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 drink fluids. If grade ≤1 was not reached within 24 hours, treatment was temporarily discontinued until diarrhea resolved. Dose reductions, omissions, and modifications occurred for grade ≥3 or persistent grade 2 diarrhea.1,8

References

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

2Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

3Goetz 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

4Johnston 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. http://dx.doi.org/10.1038/s41523-018-0097-z

5Sledge GW, 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. http://dx.doi.org/10.1200/JCO.2017.73.7585

6Dickler 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. Published correction appears in Clin Cancer Res. 2018;24(21):5475. http://clincancerres.aacrjournals.org/content/24/21/5485.article-info

7Tolaney 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) [abstract]. Cancer Res. 2017;77(suppl 4):P6-15-01. http://cancerres.aacrjournals.org/content/77/4_Supplement/P6-15-01

8Rugo 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

Glossary

AE = adverse event

GCSF = granulocyte colony stimulating factor

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2018 M07 29


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