Pharmaceutical giant Eli Lilly has boasted positive topline results from its primary analysis of a Phase III trial with breast cancer drug, Verzenio (abemacilib).
The overall survival (OS) analysis – pulled from the Phase III monarchE trial (NCT03155997) – found that two years of treatment with the CDK4/6 inhibitor plus endocrine therapy (ET) offers statistically significant improvements to OS over ET alone.
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Seven-year landmark analysis also revealed that Verzenio can boost disease-free survival (IDFS) and distant relapse-free survival (DRFS) in patients, while maintaining a safety profile consistent with previous studies.
This impact was seen in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.
Verzenio was approved in this patient population when used alongside ET in 2021, as the monarchE trial demonstrated that the oral, twice-daily drug could significantly reduce a patient’s risk of recurrence by 34%. Verzenio plus ET also reduced KI-67 scores – a common biomarker of cancer cell proliferation – to ≥20% in patients, highlighting the combination’s potential to stave off tumour growth.
Since then, the FDA expanded the drug’s eligibility criteria in the patient population to include those who do not have a KI-67 score of more than 20% – making the combination more widely available to patients in this indication.
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By GlobalDataHowever, Verzenio’s sales in this indication could be threatened by Novartis’ CDK4/6 inhibitor, Kisqali, which gained an FDA label expansion in September 2024 to cover this patient population when used alongside an aromatase inhibitor.
In 2022, after five years on the market, the drug hit blockbuster status – with its continued growth trajectory showing no signs of plateauing until 2030. Notably, analysts at GlobalData, Clinical Trials Arena‘s parent company, forecast that Kisqali will bring in $9bn for the Swiss pharma by 2031, a value significantly higher than the company’s cardiovascular pill and flagship product, Entresto (sacubitril/valsartan).
Though Kisqali will be fierce competition for Lilly, GlobalData analysts predict that the two drugs will be neck and neck in terms of sales, with Verzenio forecasted to earn $8.3bn for Eli Lilly in 2030 at the peak of its commercial success.
