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March 18, 2021

Lilly reports positive PRO from high-risk early breast cancer trial

Eli Lilly has reported positive patient-reported outcomes (PRO) from a late-stage trial testing the efficacy of Verzenio (abemaciclib) in treating high-risk early breast cancer (EBC).

Eli Lilly has reported positive patient-reported outcomes (PRO) from a late-stage trial testing the efficacy of Verzenio (abemaciclib) in treating high-risk early breast cancer (EBC).

The move comes after a primary outcome analysis of the Phase III monarchE trial showed Verzenio in combination with endocrine therapy (ET) reduced the risk of breast cancer recurrence by 28.7% compared with ET alone.

The ongoing multicentre, randomised, open-label study is assessing investigational use of Verzenio in combination with standard adjuvant ET for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high-risk EBC.

The PRO analysis was based on information procured from both arms of the study. It measured the subjects’ experiences with side effects, symptoms, and other health-related data.

One of the analyses found that nearly 70%-75% of the patients in both arms reported being bothered ‘a little bit’ or ‘not at all’ by treatment-related side effects.

The data indicate that the addition of Verzenio did not result in clinically meaningful difference in patients complaining about treatment side effects.

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The company presented the data at the virtual 17th St Gallen International Breast Cancer Conference.

Dana-Farber Cancer Institute’s Dr Sara M Tolaney said: “The patient-reported outcomes analysis represents another step forward in our understanding of the impact for patients who receive abemaciclib in the early breast cancer setting.

“These important data demonstrate actual patient-reported outcomes, which are the first to be reported for a CDK4 & 6 inhibitor in the early breast cancer setting.

“These analyses continue to reaffirm our confidence in abemaciclib, and its potential to make a difference for those with high risk early breast cancer.”

Lilly recently released detailed results of a Phase II TRAILBLAZER-ALZ study conducted to determine the efficacy of investigational antibody donanemab for treating Alzheimer’s disease.

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