Benzinga | Oct 28, 2021 04:01PM EDT

Eli Lilly & Co Say Additional Verzenio Phase 3 MonarchE Trial Data Published In Annals Of Oncology

Today, overall survival (OS) data from Eli Lilly and Company's (NYSE:LLY) Verzenio(r) (abemaciclib) Phase 3 monarchE study were published in a Letter to the Editor in the Annals of Oncology. These OS data, while immature, have been published to address questions regarding the recent approval by the U.S. Food and Drug Administration (FDA) in a subgroup of the population studied in the monarchE trial. Patients participating in monarchE continue to be followed over time while overall survival data mature.

Updated data from the Phase 3 monarchE study were recently disclosed in Annals of Oncology and presented at the October 14 European Society for Medical Oncology (ESMO) Virtual Plenary. On October 12, the FDA approved Verzenio in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ?20% as determined by an FDA-approved test.1 As previously reported, overall survival was a key secondary outcome measure for the monarchE study and an important component of the FDA review.