Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

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Verzenios® ▼ (abemaciclib): Analys av undergrupper i MONARCH 2 och MONARCH 3

I en undergruppsanalys av patienter i MONARCH 2 och MONARCH 3 observerades en betydande fördel med Verzenios (abemaciclib) i undergrupper med dålig prognos.

Detailed Information

A combined exploratory analysis of MONARCH 2 and MONARCH 3 was conducted in women with HR+, HER2- ABC to determine significant prognostic factors and to examine patient and disease characteristics that may inform in whom and when abemaciclib should be initiated.1

  • In MONARCH 2, patients whose disease had progressed while receiving ET were administered fulvestrant + abemaciclib/placebo.2

  • In MONARCH 3, patients received a NSAI + abemaciclib/placebo as initial therapy for advanced disease.3

While all subpopulations benefited from the addition of abemaciclib to ET regardless of prognosis, substantial benefit of abemaciclib (characterized by large increases in PFS [HRs=0.4-0.5] and ORR [>30%]) was observed in poor prognosis subgroups with liver metastases, progesterone receptor-negative tumors, and high-grade tumors.1

A subpopulation treatment effect pattern plot analysis of TFI of the MONARCH 3 patients who had received adjuvant ET demonstrated that patients who had a shorter TFI (<36 months) had a worse prognosis and received relatively greater benefit from abemaciclib plus NSAI than did patients with a longer TFI (>or= 36 months).1

References

1. Di Leo A, O'Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41. http://dx.doi.org/10.1038/s41523-018-0094-2

2. 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

3. 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

ABC = advanced breast cancer

ET = endocrine therapy

HER2- = human epidermal growth factor receptor 2-negative

HR = hazard ratio

HR+ = hormone receptor-positive

NSAI = nonsteroidal aromatase inhibitor

ORR = objective response rate

PFS = progression-free survival

TFI = treatment-free interval

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 2019 M06 25

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