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Lilly reports survival benefit with Verzenio in high-risk early breast cancer

The findings are based on Lilly’s phase 3 monarchE trial
- PMLiVE

Eli Lilly has announced that its new therapeutic Verzenio (abemaciclib), given alongside standard endocrine therapy, improves overall survival in people with high-risk, early-stage breast cancer that is hormone receptor-positive (HR+) and Human Epidermal Growth Factor (HER)2-negative.

The findings are based on Lilly’s phase 3 monarchE trial, which analysed more than 5,600 patients across 38 countries. The study compared two years of treatment with Verzenio and endocrine therapy against endocrine therapy alone. At the seven-year analysis, the combination not only reduced the risk of recurrence but also extended patients’ overall survival.

This type of breast cancer is the most common subtype, accounting for about 70% of cases. While many patients improve after surgery and endocrine treatment, those whose cancer has spread to the lymph nodes, have large tumours, or a high tumour grade face a greater chance of the disease returning – often as metastatic cancer. Verzenio has the potential to meet this critical unmet medical need.

“Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “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.”

Verzenio is an oral tablet taken twice daily. No new safety concerns were identified. Detailed results will be presented at an upcoming Lilly medical meeting and submitted for peer-reviewed publication.

Ella Day
1st September 2025
From: Research
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