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monarchE

Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer

Phase 3N = 5,637NCT03155997

Population
HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence (four or more positive nodes, or one to three nodes with tumour size 5 cm or larger, grade 3, or, in cohort 2, central Ki-67 of 20% or higher)
Design
Open-label, randomized phase III trial (1:1) of standard-of-care adjuvant endocrine therapy with or without abemaciclib 150 mg twice daily for 2 years
Primary endpoint
iDFS
Arms
  • Abemaciclib plus endocrine therapy (experimental, n = 2,808): Abemaciclib 150 mg twice daily for 2 years plus standard-of-care endocrine therapy
  • Endocrine therapy alone (control, n = 2,829): Standard-of-care adjuvant endocrine therapy
People
Johnston SRD, monarchE Committee Members and Investigators
iDFSHR 0.75 (95% CI 0.60–0.93)Δ 24-month iDFS+3.5 pointsiDFSHR 0.664 (95% CI 0.578–0.762)Δ 48-month iDFS+6.4 pointsOSHR 0.929 (95% CI 0.748–1.153)OSHR 0.842 (95% CI 0.722–0.981)
Show the numbers
Results reported for monarchE
EndpointAnalysisAbemaciclib plus endocrine therapyEndocrine therapy aloneEffect
iDFSinterimJohnston 202092.2% at 2 y88.7% at 2 yHR 0.75 (95% CI 0.60–0.93)P=.01Preplanned efficacy interim analysis; 323 invasive disease-free survival events.
iDFSinterimmedian follow-up 42 monthsJohnston 202385.8% at 4 y (84.2–87.3%)79.4% at 4 y (77.5–81.1%)HR 0.664 (95% CI 0.578–0.762)P<0.0001Preplanned overall survival interim analysis, with updated invasive disease-free survival. Nominal p-value.
OSinterimmedian follow-up 42 monthsJohnston 2023——HR 0.929 (95% CI 0.748–1.153)P=0.50Deaths: 157 with abemaciclib plus endocrine therapy, 173 with endocrine therapy alone.
OSprimarymedian follow-up 76.2 monthsJohnston 202686.8% at 7 y85% at 7 yHR 0.842 (95% CI 0.722–0.981)P=0.027Primary OS analysis, which met the prespecified boundary for significance; 661 deaths.
iDFSlong term-updatemedian follow-up 76.2 monthsJohnston 202677.4% at 7 y70.9% at 7 yHR 0.734 (95% CI 0.657–0.820)
DRFSlong term-updatemedian follow-up 76.2 monthsJohnston 202680% at 7 y74.9% at 7 yHR 0.746 (95% CI 0.662–0.840)
iDFSCohort 1 (the FDA-labelled high-risk population)interimSource 202385.5% at 4 y (83.8–87.0%)78.6% at 4 y (76.7–80.4%)HR 0.653 (95% CI 0.567–0.753)FDA restricted the indication to cohort 1; in cohort 2 the page reports more deaths with abemaciclib plus endocrine therapy (10 of 253 vs 5 of 264).
Results reported for monarchE
EndpointAnalysisAbemaciclib plus endocrine therapyEndocrine therapy aloneEffect
iDFSinterimJohnston 202092.2% at 2 y88.7% at 2 yHR 0.75 (95% CI 0.60–0.93)P=.01Preplanned efficacy interim analysis; 323 invasive disease-free survival events.
iDFSinterimmedian follow-up 42 monthsJohnston 202385.8% at 4 y (84.2–87.3%)79.4% at 4 y (77.5–81.1%)HR 0.664 (95% CI 0.578–0.762)P<0.0001Preplanned overall survival interim analysis, with updated invasive disease-free survival. Nominal p-value.
OSinterimmedian follow-up 42 monthsJohnston 2023——HR 0.929 (95% CI 0.748–1.153)P=0.50Deaths: 157 with abemaciclib plus endocrine therapy, 173 with endocrine therapy alone.
OSprimarymedian follow-up 76.2 monthsJohnston 202686.8% at 7 y85% at 7 yHR 0.842 (95% CI 0.722–0.981)P=0.027Primary OS analysis, which met the prespecified boundary for significance; 661 deaths.
iDFSlong term-updatemedian follow-up 76.2 monthsJohnston 202677.4% at 7 y70.9% at 7 yHR 0.734 (95% CI 0.657–0.820)
DRFSlong term-updatemedian follow-up 76.2 monthsJohnston 202680% at 7 y74.9% at 7 yHR 0.746 (95% CI 0.662–0.840)
iDFSCohort 1 (the FDA-labelled high-risk population)interimSource 202385.5% at 4 y (83.8–87.0%)78.6% at 4 y (76.7–80.4%)HR 0.653 (95% CI 0.567–0.753)FDA restricted the indication to cohort 1; in cohort 2 the page reports more deaths with abemaciclib plus endocrine therapy (10 of 253 vs 5 of 264).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
iDFSiDFSOSOSiDFSDRFSiDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
iDFS0.750.6–0.93
iDFS0.6640.578–0.762
OS0.9290.748–1.153
OS0.8420.722–0.981
iDFS0.7340.657–0.82
DRFS0.7460.662–0.84
iDFS0.6530.567–0.753
Primary publication: Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, et al. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. PubMedDOI

Appears in

Sources

  1. Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, et al. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998.

    PubMedDOI

  2. Johnston SRD, Toi M, O'Shaughnessy J, Rastogi P, Campone M, Neven P, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90.

    PubMedDOI

  3. Johnston S, Martin M, O'Shaughnessy J, Hegg R, Tolaney SM, Guarneri V, et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026;37(2):155-165.

    PubMedDOI

  4. US Food and Drug Administration. FDA expands early breast cancer indication for abemaciclib with endocrine therapy. 3 March 2023.

    Source