Verzenios ® (abemaciklib)

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Är Verzenios® ▼ (abemaciklib) effektivt hos äldre patienter med metastaserad bröstcancer?

Sammantaget noterades inga åldersbaserade skillnader i säkerhet eller effekt av Verzenios (abemaciklib) i kliniska studier.

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Progression Free Survival (PFS) of Age-Specific Subgroups in MONARCH-2 and MONARCH-3

We observed a consistent PFS benefit with abemaciclib plus endocrine therapy (ET) vs. placebo plus ET across three age-specified subgroups in MONARCH-2 and MONARCH-3. Please find the results in PFS by Age Subgroups in MONARCH 2 and PFS by Age Subgroups in MONARCH 3.1

 

PFS by Age Subgroups in MONARCH 21

 

Abemaciclib + ET
PFS, months

Placebo + ET
PFS, months

HR (95% CI)

Interaction P-Valuea

<65 Years

17.39

10.78

0.523 (0.402-0.681)

.695

65-74 Years

14.37

8.12

0.633 (0.426-0.941)

≥75 Years

13.91

5.75

0.615 (0.340-1.112)

Abbreviations: ET= endocrine therapy; HR = hazard ratio; PFS = progression-free survival.

aP-value corresponds to the interaction test between age and treatment.

PFS by Age Subgroups in MONARCH 31

 

Abemaciclib + ET
PFS, months

Placebo + ET
PFS, months

HR (95% CI)

Interaction P-Valuea

<65 Years

27.48

13.97

0.480 (0.346-0.666)

.634

65-74 Years

28.18

24.20

0.635 (0.395-1.020)

≥75 Years

31.07

9.11

0.541 (0.258-1.134)

Abbreviations: ET= endocrine therapy; HR = hazard ratio; PFS = progression-free survival.

aP-value corresponds to the interaction test between age and treatment.

Description of the Age-Specific Subgroup Analysis Set of MONARCH-2 and MONARCH-3

The median age of patients was

  • 60 years (range 32-91) in MONARCH-2, and 
  • 63 years (range 32-88) in MONARCH-3.2

We performed an exploratory subgroup analysis of MONARCH-2 and MONARCH-3 with the pooled safety data of 1152 patients.1 The data included

  • 688 (59.7%) patients <65 years
  • 331 (28.7%) patients between 65 and 74 years, and 
  • 133 (11.5%) patients ≥75 years.1

Of those patients, 768 women received abemaciclib plus ET, and 384 women received placebo plus ET.1

The baseline disease characteristics were generally balanced among shared characteristics between MONARCH 2 and MONARCH 3, across treatment arms, and between age groups.1

Age did not effect the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24‑91 years).2

References

1Goetz MP, Okera M, Wildiers H, et al. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021;186(2):417-428. https://doi.org/10.1007/s10549-020-06029-y

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.

Datum fӧr senaste ӧversyn 2021 M03 12


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