Eli Lilly’s Verzenio shows survival improvement in breast cancer study

Eli Lilly announced results from the MONARCH 3 clinical trial, which will be presented during the 2023 San Antonio Breast Cancer Symposium. MONARCH 3 evaluated Verzenio – abemaciclib – in combination with an aromatase inhibitor – AI – compared to an AI alone as initial endocrine-based therapy for post-menopausal patients with hormone receptor positive – HR+ -, human epidermal growth factor receptor 2 negative – HER2- – advanced or metastatic breast cancer. At eight years of follow-up, MONARCH 3 showed women taking Verzenio and an AI had a median overall survival of more than 5.5 years – an increase of 13.1 months vs. the control arm in the intent-to-treat population, although statistical significance for the OS outcome was not reached. For women with visceral organ metastases, data showed a median OS of more than five years, with an increase in median OS of 14.9 months in the Verzenio arm vs. the control arm. The OS results for this subpopulation were also not statistically significant. The median progression free survival – PFS – benefit, the primary endpoint of the MONARCH 3 study, was maintained, with substantial difference in 6-year PFS rates. PFS statistical significance was achieved in an interim analysis in 2017, leading to global regulatory approvals for this indication in 2018. No new safety signals were observed with longer-term use.