Verzenios ® ▼ (abemaciclib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Verzenios Summary of Product Characteristics (SmPC)

Is Verzenios® ▼ (abemaciclib) still efficacious after dose reduction due to adverse events?

We did not find differences in progression free survival (PFS) for patients who had to reduce the abemaciclib dose from 150 mg to 100 mg or 50 mg due to adverse events.

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Results of the Time-Dependent Covariate Analysis of PFS After Dose Reduction in the Phase-3-Clinical Trials

We performed a time-dependent covariate analysis to examine the association between the current dose level (150 mg, 100 mg, and 50 mg) and PFS in the MONARCH 2 and MONARCH 3 trials.

Compared to being treated at the 150 mg dose level, patients in MONARCH 2 experienced no difference in PFS when their dose was reduced to 

  • 100 mg (HR=1.033; 95% CI: 0.679-1.572; p=.8793), or
  • 50 mg (HR=0.923; 95% CI: 0.499-1.706; p=.7973).1

Likewise, patients in MONARCH 3 experienced no difference in PFS when their dose was reduced to 

  • 100 mg (HR=0.764; 95% CI: 0.467-1.251), or
  • 50 mg (HR=0.985; 95% CI: 0.511-1.902).1

Efficacy of Lower Starting Doses at Treatment Initiation

We have no information available on starting doses of less than 150 mg.

The recommended dose of abemaciclib is 150 mg twice daily in combination with endocrine therapy.2

References

1Rugo HS, Sledge GW Jr, Johnston S, et al. The association of early toxicity and outcomes for patients treated with abemaciclib. Poster presented at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Accessed September 3, 2020. https://meetinglibrary.asco.org/record/161891/poster

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

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.

Date of Last Review: July 09, 2021


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