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Lilly's Verzenio combo shows additional breast cancer survival benefit in new Phase 3 data

Published on 31/07/19 at 11:57am

Eli Lilly has revealed new Phase 3 data on its CDK4 & 6 inhibitor Verzenio (abemaciclib), demonstrating its efficacy in extending overall survival when combined with AstraZeneca’s Faslodex (fulvestrant) in the treatment of breast cancer.

The study of 669 participants from which the data was drawn focused on the efficacy of the drug combo in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy. It was found that the combo met the secondary endpoint of the study, generating a “statistically significant improvement in overall survival”.

Verzenio has already secured approval with Faslodex in the treatment of HR+ and HER2- breast cancer, to be used following disease progression on endocrine therapy, as well as for use on its own in patients who have already received endocrine therapy and chemotherapy after their cancer had metastasised. This was off the back of data from the same study, showing that the combination improved progression-free survival by a median 16.4 months, compared to 9.3 months with Fasoldex alone – meeting the trial’s primary endpoint.

"This definitive overall survival analysis from MONARCH 2 showed significant improvement in overall survival for women living with HR+, HER2- metastatic breast cancer, a complex disease that remains incurable," explained Dr Maura Dickler, Vice President of Late Stage Development at Lilly Oncology. "For many doctors and patients overall survival is the most important endpoint. It's been difficult in the past to achieve meaningful improvements in this endpoint for women with advanced breast cancer, including those whose cancer progressed after prior endocrine therapy."  

Lilly Oncology President Anne White, meanwhile, commented: "I believe we must continue to fight this devastating disease because the women who are living with metastatic breast cancer want to do everything they can to lead more fulfilling lives and be there for those who need them most, While Verzenio had already shown an  impressive benefit for progression-free survival, we are delighted that Verzenio is the first and only CDK4 & 6 inhibitor in combination with fulvestrant that has significantly extended life for both pre/peri- and postmenopausal women."

Matt Fellows

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