All patients had completed or discontinued the two-year Verzenio course, and safety remained consistent with previous reports, indicating no new safety concerns.

Eli Lilly announced positive results from the Phase 3 monarchE trial, demonstrating that two years of Verzenio (abemaciclib) combined with endocrine therapy significantly improves overall survival in patients with high-risk, HR+, HER2-, node-positive early breast cancer.

Results showed a statistically significant and clinically meaningful overall survival benefit, validating Verzenio as an effective treatment for this patient group.

The long-term data support Verzenio's role as a standard of care, showing durable treatment effects over seven years.

The trial involved 5,637 patients across 600 sites in 38 countries, focusing on a high-risk, node-positive early breast cancer population with specific criteria such as tumor size, grade, and positive lymph nodes.

A seven-year follow-up confirmed that Verzenio provides sustained benefits in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), with no new safety concerns reported.

The safety profile of Verzenio includes risks such as diarrhea, neutropenia, ILD/pneumonitis, liver enzyme elevations, and VTE, with management strategies outlined for adverse effects.

Further results will be presented at future medical meetings, published in peer-reviewed journals, and discussed with regulatory agencies, reinforcing Verzenio's position as a treatment option.

Verzenio is an oral CDK4/6 inhibitor approved for HR+, HER2- breast cancers in both adjuvant and metastatic settings, with data supporting its inclusion in treatment guidelines, including NCCN recommendations.

Previous findings demonstrated a 25.3% reduction in recurrence risk with abemaciclib, with five-year follow-up data confirming sustained efficacy and absolute improvements in IDFS and DRFS.

The FDA approved abemaciclib for adjuvant use in high-risk, hormone receptor–positive, HER2-negative, node-positive early breast cancer with a Ki-67 score of 20% or greater in October 2021, expanding indications in March 2023.

The results validated the overall survival benefit of Verzenio, with safety profiles consistent with earlier data, further establishing its role in high-risk early breast cancer treatment.

The trial's design included two cohorts based on high-risk features, with treatment for two years and endocrine therapy continued for at least five years if appropriate.