Eli Lilly Releases Phase 3 monarchE Trial Results Showing That Two Years Of Verzenio Plus Endocrine Therapy Reduced The Risk Of Death By 15.8% Compared To Endocrine Therapy Alone And Delivered Sustained Improvements In Invasive Disease-Free And Distant Relapse-Free Survival For Patients With HR+, HER2-, High-Risk Early Breast Cancer

Author: Benzinga Newsdesk | October 17, 2025 08:05am

Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, high-risk early breast cancer

Seven-year results from the Phase 3 monarchE trial also show Verzenio plus endocrine therapy demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival

These data were simultaneously published in Annals of Oncology and presented as a late-breaking oral session at the European Society for Medical Oncology (ESMO) Annual Meeting

= Eli Lilly and Company (NYSE:LLY) today announced results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial showing that two years of adjuvant Verzenio plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.

These results were published in the Annals of Oncology and will be shared in a late-breaking oral presentation at the ESMO Annual Meeting today, Friday, October 17, at 2:50 PM CEST/08:50 AM ET in Berlin, Germany. These data are being submitted to regulatory health authorities globally.

"For patients, survival is what matters most — and abemaciclib plus endocrine therapy represents the first contemporary medicine in over two decades to deliver a clear improvement in overall survival in the adjuvant setting," said Stephen Johnston, M.D., Ph.D., Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust (London, U.K.) and lead investigator for monarchE. "These results represent an important step forward in the treatment of high-risk HR+, HER2− early breast cancer."

The data presented include results from the primary OS analysis reflecting a median follow-up of 6.3 years, with more than 75% of patients having been followed for at least four years after completion of the two-year Verzenio treatment period. In the intent-to-treat (ITT) population, Verzenio plus ET reduced the risk of death by 15.8% compared to ET alone [7-year overall survival (OS) rate: 86.8% vs. 85.0%; hazard ratio (HR) 0.842; 95% CI: 0.722–0.981; 2-sided p=0.027].

In addition, treatment with Verzenio plus ET led to a sustained reduction in risk of recurrence at seven years, continuing to demonstrate the deep IDFS and DRFS benefit and carryover effect previously seen at five years in monarchE. Notably, 32% fewer patients treated with Verzenio plus ET were living with metastatic disease compared to those receiving ET alone (6.4% vs 9.4%, respectively). Continued long-term follow-up from this trial will help to determine whether this ongoing difference in patients alive with metastatic disease translates into further deepening of survival benefit with time. Results for Cohort 1 were consistent with those for the ITT population across OS, IDFS and DRFS results, and the benefit was also demonstrated across subgroups.

"These results represent an important advancement in the care of node-positive, high-risk HR+, HER2- disease by delivering meaningful reductions in recurrence and improving survival," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These findings reinforce two years of Verzenio plus endocrine therapy as the standard of care for node-positive, high-risk disease, offering renewed hope for patients facing this diagnosis."

Safety findings were consistent with the known profile of Verzenio and prior monarchE analyses. No new safety signals or delayed toxicities were observed. Adverse events were generally managed with dose modifications, consistent with prior monarchE analyses.

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