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

In Clinical Studies News by Barbara Jacoby

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From: clinicaltrialsarena.com

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). 

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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.

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.”