Lilly's Verzenio® (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment

• 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.

TORONTO, Oct. 17, 2025 /CNW/ - Eli Lilly and Company 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 2:00 PM CEST/08:00 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 ET 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. "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 ET 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.

About the monarchE Study
monarchE was a global, randomized, open-label, two cohort, multicentre Phase 3 clinical trial that enrolled 5,637 adults with HR+, HER2-, node-positive EBC at high risk of recurrence. The study enrolled patients across more than 600 sites in 38 countries and is the only adjuvant study designed to investigate a CDK4/6 inhibitor specifically in a node-positive, high-risk EBC population. To be enrolled in Cohort 1 (n=5,120), which is the FDA-approved population, patients had to have 4+ positive nodes or 1-3 positive nodes and at least one of the following: tumours that were ≥5 cm or Grade 3. Patients enrolled in Cohort 2 could not have met the eligibility criteria for Cohort 1. To be enrolled in Cohort 2 (n=517), patients had to have 1-3 positive nodes and Ki-67 score ≥20%. Patients in each cohort were randomized 1:1 to receive either Verzenio 150 mg twice daily plus standard-of-care adjuvant ET (Cohort 1, n=2,555; Cohort 2, n=253) or standard-of-care adjuvant ET alone (Cohort 1, n=2,565; Cohort 2, n=264) for 2 years. ET continued for at least 5 years if deemed medically appropriate. The primary endpoint was IDFS. Consistent with expert guidelines, IDFS was defined as the length of time before breast cancer comes back, any new cancer develops, or death. OS was a key secondary endpoint in monarchE. The OS analysis plan was amended after the primary analysis of IDFS, following consultation with regulators, to increase the number of required OS events from 390 to 650 to ensure a minimum follow-up of at least 5 years and enable a more mature survival dataset.^1,2

About Early Breast Cancer and Risk of Recurrence
It is estimated that 90 per cent of all breast cancers are detected at an early stage.³ Approximately 70per cent of all breast cancer cases are the HR+, HER2- subtype.³ Although the prognosis for HR+, HER2- EBC is generally positive, 20 per cent of patients will experience recurrence potentially to incurable metastatic disease.⁴ Risk of recurrence is greatest within the initial two to three years post-diagnosis, particularly in patients with node-positive, high risk EBC.⁴ Factors associated with high risk of recurrence include: positive nodal status, large tumour size (≥5 cm), high tumour grade (Grade 3), and high rate of cellular proliferation [Ki-67 score (≥20%)].⁴

Node-positive means that cancer cells from the tumour in the breast have been found in the lymph nodes in the armpit area. Although the breast cancer is removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of the cancer returning and spreading.

About Breast Cancer
Breast cancer has now surpassed lung cancer as the most diagnosed cancer worldwide, according to GLOBOCAN.⁵ In the report, breast cancer had an age standardized rate (ASR) of 82.1 per 100,000, which means that about 1 in every 8 of new Canadian cancer diagnosis in 2024 was breast cancer.⁶ With approximately 670,000 deaths in 2022, breast cancer is the fourth-leading cause of cancer death worldwide. In Canada, an estimated 30,500 Canadian women were diagnosed with breast cancer, by the end of 2024.⁶ This represents 25% of all new cancer cases in women in 2024.⁶

About Verzenio® (abemaciclib) ⁷
Verzenio^® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet.

Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumour size. Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.

About Lilly Canada
Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit www.lilly.com/en-CA, or follow us on LinkedIn.

References

1.	Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE) [published online ahead of print, September 20, 2020]. J Clin Oncol. doi:10.1200/JCO.20.02514.
2.	U.S. Food and Drug Administration. Clinical Review of Abemaciclib (Verzenio). Silver Spring, MD: Center for Drug Evaluation and Research; 2021. Available at: https://www.ncbi.nlm.nih.gov/books/NBK601722/. Accessed August 26, 2025.
3.	PA Fasching et al. Identification of Patients with Early HR+ HER2− Breast Cancer at High Risk of Recurrence: A Pooled Analysis. 2024. PMC10853032. Accessed August 26, 2025.
4.	Wu X, Multimodal Recurrence Risk Prediction Model for HR+/HER2 Early Breast Cancer Following Adjuvant Chemo Endocrine Therapy: Integrating Pathology Image and ClinicoPathological Features. Breast Cancer Research. 2025. https://doi.org/10.1186/s13058-025-01968-0. Accessed August 26, 2025.
5.	International Agency for Research on Cancer. GLOBOCAN 2022. https://gco.iarc.who.int. Accessed August 26, 2025.
6.	Canadian Cancer Society. Breast cancer statistics. https://cancer.ca/en/cancer-information/cancer-types/breast/statistics. Accessed August 26, 2025
7.	Verzenio® Product Monograph. Eli Lilly Canada Inc. July 24, 2025.

SOURCE Eli Lilly Canada Inc.

For more information, please contact: Amanda Meek, Eli Lilly Canada Inc., [email protected]