Positive new data on abemaciclib in breast cancer

Following a pre-planned interim analysis for MONARCH 3, the closely watched breast cancer treatment trial abemaciclib met its primary endpoint of demonstrating statistically-significant improvement in progression-free survival (PFS), said the drug’s developer, Eli Lilly (NYSE: LLY), shares of which rose 1.5% to $83.10 on the news.

In addition, Lilly noted, improvement was shown in a key secondary endpoint of objective response rate (ORR). The Phase III study evaluated abemaciclib, a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, in combination with an aromatase inhibitor (letrozole or anastrozole) compared to treatment with an aromatase inhibitor alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Detailed efficacy and safety results will be presented at a medical meeting in the second half of the year.

Last year, Lilly reported that a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) recommended the study continue without modification as the interim efficacy criteria were not met.