publication date: Mar. 30, 2017

Breast Cancer Phase III MONARCH 2 study of abemaciclib meets primary endpoint of PFS

Eli Lilly and Co. said its MONARCH 2 trial of abemaciclib met the primary endpoint of progression-free survival. The phase III study evaluated abemaciclib, a cyclin-dependent kinase  4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer who have relapsed or progressed after endocrine therapy.

The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. Detailed efficacy and safety results will be presented at an upcoming medical meeting.

The global phase III, double-blind study was designed to evaluate the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with advanced (locoregionally recurrent or metastatic) breast cancer. The intent-to-treat population of 669 patients was randomized to receive abemaciclib or placebo orally twice a day on a continuous dosing schedule, given in combination with fulvestrant at its approved dose and schedule, until disease progression.

Patients enrolled in the study had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease. Patients who had received chemotherapy in the metastatic setting were not eligible … Continue reading CCL March 2017 – Phase III MONARCH 2 study of abemaciclib meets primary endpoint of PFS

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