publication date: Dec. 22, 2016

Breast Cancer Lilly Presents Phase II Data on Abemaciclib in Early Breast Cancer

A phase II study of abemaciclib, a cyclin-dependent kinase 4 and CDK 6 inhibitor, met its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation, after two weeks of treatment.

Abemaciclib is sponsored by Eli Lilly and Co.

Final data from the neoMONARCH phase II trial were presented during the official press program at the 2016 San Antonio Breast Cancer Symposium. The study evaluated abemaciclib, both alone or in combination with the non-steroidal aromatase-inhibitor anastrozole, in postmenopausal women with previously untreated early stage hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

The phase II neoMONARCH trial was a randomized, multi-center, open-label study that enrolled 225 patients who had at least one measurable tumor ≥1 cm, adequate organ function, and an ECOG performance status of ≤1.

Patients were randomized to one of three trial arms: 1) twice-daily abemaciclib monotherapy (150mg) for two weeks; 2) twice-daily abemaciclib (150mg) along with once-daily anastrozole (1mg) for two weeks; or 3) once-daily anastrozole monotherapy (1mg) for two weeks.

All patients received an initial biopsy prior to randomization to assess baseline Ki67 expression. After the initial two-week treatment period, patients underwent a second tumor biopsy and Ki67 was assessed again.

The … Continue reading CCL Dec 2016 – Lilly Presents Phase II Data on Abemaciclib in Early Breast Cancer

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