Abemaciclib+fulvestrant extends survival in advanced breast cancer

  • Sledge GW & al.
  • JAMA Oncol
  • 29 Sep 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Adding abemaciclib to fulvestrant prolonged survival by 9.4 months in the MONARCH2 phase 3 trial of women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2) advanced breast cancer that advanced on endocrine therapy.

Why this matters

  • OS benefit was consistent regardless of menopausal status.
  • Benefit was consistent in women with endocrine resistance or primary visceral disease.

Study design

  • Multicenter double-blind trial of 669 women (median age, 59 years) with advanced disease, randomly assigned 2:1 to receive fulvestrant 500 mg with either abemaciclib or placebo (150 mg, every 12 hours) on a continuous schedule. 
  • Funding: Eli Lilly and Company.

Key results

  • Median survival, 47.7 months.
  • Abemaciclib+fulvestrant extended survival by 9.4 months (46.7 vs 37.3 months vs fulvestrant alone; HR, 0.757; P=.01).
  • Results were even better for those with these stratification factors:
    • Primary (vs secondary) resistance to prior endocrine therapy (HR, 0.686; 95% CI, 0.451-1.043).
    • Visceral metastasis (HR, 0.675; 95% CI, 0.511-0.891).

  • Abemaciclib+fulvestrant was also associated with:
    • longer time to disease progression (median, 23.1 vs 20.6 months),
    • longer time to chemotherapy (median, 50.2 vs 22.1 months), and
    • longer chemotherapy-free survival (median, 25.5 vs 18.2 months).

  • No new safety problems emerged.

Limitations

  • Observation time not sufficient for some stratification factors.
  • Interim data.

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