Eli Lilly’s Verzenio (abemaciclib) boosted overall survival (OS) in the adjuvant breast cancer setting during a late-stage trial.
In the Phase III monarchE study, (NCT02763566), Verzenio plus endocrine therapy (ET) significantly reduced a patient’s risk of death compared with ET alone – slashing rates by 15.8%.
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Meanwhile, 86.8% of those given the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor plus ET were alive at the seven-year mark. This was compared to the 85% rate seen in the ET-only arm.
Patients treated with Verzenio also experienced sustained improvements in both invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), with 32% less patients living with metastatic disease compared with the ET monotherapy arm after a median follow-up of 6.3 years. However, it is yet to be determined if this will translate into a further OS benefit.
The positive impact of Verzenio and ET as an adjuvant combination was seen in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative high-risk breast cancer.
According to Lilly, these results mark Verzenio’s status as the first contemporary therapy to show benefit in this patient population for more than 20 years. They were first presented at a late-breaking oral presentation at the ongoing 2025 European Society of Medical Oncology (ESMO) congress, which is being held from 17–21 October in Berlin, Germany.
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By GlobalDataThese findings follow positive topline results from the Phase III monarchE trial shared in August 2025, which saw Verzenio-ET reduce a patient’s risk of recurrence by 34%.
Following the outcome of this late-stage trial, Eli Lilly will share these data with global regulatory authorities.
Verzenio in the breast cancer treatment paradigm
While Eli Lilly’s Verzenio first won US Food and Drug Administration (FDA) approval in certain advanced or metastatic breast cancer indications back in 2017, the drug has since seen numerous label extensions. Now, its use has been expanded for use in patients with node-positive and high-risk early disease, as well as for use as a initial treatment.
Through this enhanced market penetration, Verzenio has become a blockbuster seller for Lilly, raking in $5.3bn for the Indiana-based pharma in 2024.
Moving forward, analysts at GlobalData forecast that the drug’s sales will continue to flourish, reaching a peak of $8.1bn in 2030. GlobalData is the parent company of Clinical Trials Arena.
However, it will still have to fight for market share with Novartis’ hard-hitter Kisqali (ribociclib), which was given the FDA nod alongside an aromatase inhibitor in the HR+, HER2- early breast cancer setting in 2024.
