Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Jan 18;28(1):e77-e81.
doi: 10.1093/oncolo/oyac234.

Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1

Masakazu Toi  1 , Frances Boyle  2   3 , Young-Hyuck Im  4 , Mattea Reinisch  5 , David Molthrop  6 , Zefei Jiang  7 , Ran Wei  8 , Francisco Sapunar  8 , Brenda R Grimes  8 , Sarah Cassidy Nabinger  8 , Stephen R D Johnston  9
Affiliations
Clinical Trial

Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1

Masakazu Toi et al. Oncologist. .

Abstract

The monarchE Cohort 1 patient population was enrolled based on high-risk clinicopathological features that can easily be identified as part of routine clinical breast cancer evaluation. Efficacy data from Cohort 1 demonstrate substantial evidence of benefit for adjuvant abemaciclib+ET in patients with HR+, HER2- early breast cancer at high risk of recurrence (ClinicalTrials.gov: NCT03155997 [monarchE]).

Keywords: CDK4/6; Ki-67; abemaciclib; adjuvant; early breast cancer.

PubMed Disclaimer

Conflict of interest statement

Masakazu Toi reports grants and personal fees for research and honoraria from Chugai, Takeda, Pfizer, Kyowa-Kirin, Taiho, Eisai, Daiichi-Sankyo, AstraZeneca, Shimadzu, Yakult, and Nippon Kyaku; other fees for advisory role for drug development from Kyowa-Kirin and Daiichi-Sankyo; research grants from JBCRG association, Astellas, AFI Technologies, Shionogi, and GL Science; personal and other fees from Eli Lilly and Company for advisory role; personal fees for honoraria from MSD, Exact Science, and Novartis; personal fees and other for honoraria and advisory role from Konica Minolta, Bristol Myers Squibb; other fees for advisory role from Athenex Oncology, Bertis Terumo, and Kansai Medical Net; and serves as a board of director for JBCRG Association, Organisation for Oncology and Translational Research, and Kyoto Breast Cancer Research Network, outside the submitted work. Frances Boyle reports personal fees for honoraria and advisory role for Roche, Pfizer, Eli Lilly and Company, and Novartis outside the submitted work. Mattea Reinisch reports personal fees from AstraZeneca, MSD, Eli Lilly and Company, Roche, Daichi Sankyo, Seagen, and Somatex, as well as personal fees and non-financial support from Novartis and Pfizer, outside the submitted work. Ran Wei, Francisco Sapunar, Brenda R. Grimes, and Sarah Cassidy Nabinger are full-time employees of Eli Lilly and Company and/or Eli Lilly and company shareholders. Stephen R.D. Johnston reports personal fees and other from AstraZeneca, Eli Lilly and Company, Novartis, Pfizer, Eisai, and Roche/Genentech outside the submitted work. Young-Hyuck Im, David Molthrop, and Zefei Jiang indicated no financial relationships.

Figures

Figure 1.
Figure 1.
Invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in the Cohort 1 subpopulation at additional follow-up 1 (AFU1). (a) Kaplan-Meier curve of IDFS in Cohort 1. (b) Kaplan-Meier curve of DRFS in Cohort 1. A zoomed in version is provided within each Kaplan-Meier curve to allow better visualization of curve separation.
See this image and copyright information in PMC

References

    1. Johnston SRD, Harbeck N, Hegg R, 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. 10.1200/JCO.20.02514. - DOI - PMC - PubMed
    1. Harbeck N, Rastogi P, Martin M, et al. . Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021;32(12):1571-1581. - PubMed
    1. VERZENIO™ (abemaciclib) Pharmaceuticals and Medical Devices Agency FY (April 2021-March 2022). 2021. Japan: Pharmaceuticals and Medical Devices Agency (PMDA).
    1. VERZENIOS™ (abemaciclib) European Medicines Agency. 2022. Amsterdam, Netherlands: European Medicines Agency.
    1. Rugo HS, O’Shaughnessy J, Boyle F, et al. . Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022;33(6):616-627. - PubMed

Publication types

MeSH terms

Associated data