Lilly's Verzenio® (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy Français
Treatment with Verzenio plus endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone
In the seven-year landmark analysis of monarchE, treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Results reinforce two years of Verzenio plus endocrine therapy as the standard of care in HR+, HER2-, node-positive, early breast cancer at a high risk of recurrence
TORONTO, Aug. 27, 2025 /CNW/ - On August 27, 2025, Eli Lilly and Company announced positive topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial. Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement in OS compared to ET alone in patients with hormone receptor positive (HR+), HER2-, node-positive, high-risk early breast cancer.
The seven-year landmark analysis also demonstrated sustained benefit in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), reinforcing the consistency and durability of treatment effect across endpoints.
"Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting. Achieving a statistically significant OS benefit with just two years of Verzenio therapy reinforces its differentiated profile in high-risk HR+, HER2- early breast cancer," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These data validate Verzenio as the standard-of-care for patients with node-positive, high-risk disease and increase the urgency to ensure all eligible patients are treated."
With all patients having completed or discontinued the two-year course of Verzenio, the overall safety profile of Verzenio was unchanged and consistent with previous reports.
"These new data are very important because it proves that taking Verzenio for just two years does indeed improve survival, a treatment opportunity that all eligible patients deserve to be offered as standard of care," said Karen Bell, senior medical director of Oncology at Lilly Canada. "We hope this outcome brings reassurance for Canadian patients and their families."
Detailed results will be presented at a future medical meeting, submitted for publication in a peer-reviewed journal and discussed with regulatory bodies.
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), 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 70 per cent of all breast cancers are of 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.7 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)8
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 CDK 4/6 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.
Endnotes and References
|
SOURCE Eli Lilly Canada Inc.
For more information, please contact: Amanda Meek, Eli Lilly Canada Inc., [email protected]
Share this article