Verzenio® (Abemaciclib)

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Abemaciclib: Treatment Adherence or Compliance

Median dose compliance for abemaciclib approached 100%. Approximately 8%, 16%, and 25% discontinued study drug due to an AE in MONARCH 1, 2, and 3 respectively.

Detailed Information

Treatment adherence or compliance information for abemaciclib in the MONARCH 1, MONARCH 2, and MONARCH 3 trials was collected through pill counts at each visit, and the number of doses taken relative to the number expected to be taken was summarized for each cycle.1 Compliance and dose intensity is summarized in Table 1.

Table 1. Abemaciclib Compliance and Dose Intensity1-4

 

MONARCH 1

MONARCH 2

MONARCH 3

Recommended abemaciclib dose

200 mg twice daily

150 mg twice daily

150 mg twice daily

Median dose compliance

99%

98%

98%

Relative dose intensity

89%

80%

85%

Median dose intensity

357 mg/day

273 mg/day

256 mg/day

  • Patient compliance was defined as taking ≥75% and ≤125% of the planned doses in a cycle.1

  • Compliance was calculated as the percentage of total dose taken relative to the total assigned dose (minus any dose adjustments and doses omitted for medical reasons).1

  • Dose intensity was defined as the actual cumulative amount of drug taken divided by the duration of treatment.1

  • Relative dose intensity was calculated as (actual amount of drug taken / amount of drug prescribed) x 100%.1

Overall, discontinuation due to AEs was

  • 8% in the MONARCH 1 trial

  • 16% in the MONARCH 2 trial, and

  • 25% in the MONARCH 3 trial.2-4

References

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

2. Dickler 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

3. Sledge 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

4. Johnston 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

Glossary

AE = adverse event

Fecha de la última revisión: 2019 M06 05


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