Benzinga | Sep 27, 2021 08:06AM EDT

Eli Lilly Says New Data From Verzenio MonarchE Study To Be Featured In ESMO Virtual Plenary

New data from Eli Lilly and Company's (NYSE:LLY) monarchE study for an investigational use of Verzenio(r) (abemaciclib), in combination with endocrine therapy, in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) high risk early breast cancer will be presented at the October 14 European Society for Medical Oncology (ESMO) Virtual Plenary.

Details on this presentation are shared below.

Presentation Date Thursday, October 14 at 19:30 CEST and Time:

Title: Adjuvant abemaciclib combined with endocrine therapy (ET): Updated results from monarchE

Authors: J. O'Shaughnessy et al.

Publication VP8_2021 Number:

The presentation will utilize an April 2021 data cutoff date, allowing for more follow-up relative to the analysis last presented at the San Antonio Breast Cancer Symposium in December 2020.

The abstract is embargoed until the start of the Virtual Plenary session. For more information, please visit: https://www.esmo.org/meetings/october-virtual-plenary-2021.

About the monarchE Study

monarchE is a global randomized, open-label, Phase 3 study in women and men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence. High risk of recurrence was defined by disease characteristics: either ?4 positive axillary lymph nodes (pALN) or 1-3 pALN and at least one of the following criteria: tumor size ?5 cm, histologic Grade 3, or Ki-67 index ?20%. Patients had completed definitive locoregional therapy.

A total of 5,637 patients were randomized in a 1:1 ratio to receive two years of Verzenio 150 mg twice daily plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. After the treatment period, all patients will continue on endocrine therapy for five to 10 years, as clinically indicated.

The study's primary endpoint is invasive disease-free survival (IDFS). Secondary endpoints include distant relapse-free survival (DRFS), IDFS for patients with Ki-67 index ?20%, and overall survival (OS).