Date: 2016-12-08
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 2016 San Antonio Breast Cancer Symposium (SABCS)
Company: Eli Lilly (USA - IN)
Product: abemaciclib (LY2835219)
Action
mechanism:
- cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4.
Disease: breast cancer
Therapeutic
area: Cancer - Oncology
Country: Austria, Belgium, Canada, Germany, Italy, Republic of Korea, Netherlands, Spain, Taiwan, USA
Trial
details:
- The Phase 2 neoMONARCH trial was a randomized, multi-center, open-label study that enrolled 224 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. (NCT02441946)
Latest
news:
- • On December 8, 2016, Eli Lilly announced that the neoMONARCH study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, met its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation, after two weeks of treatment. Final data from the Phase 2 trial presented during the official press program at the 2016 San Antonio Breast Cancer Symposium (SABCS) 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 (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
- The primary objective of the study was to assess Ki67 percentage change in the breast tumor after two weeks of therapy from the baseline measurement. The results showed that abemaciclib monotherapy and abemaciclib in combination with anastrozole significantly reduced Ki67 more than anastrozole alone. Following the initial two weeks of randomized treatment, all patients then went on to receive twice-daily abemaciclib (150mg) plus anastrozole (1mg) for a further 14 to 22 weeks. The study protocol also included the prophylactic use of loperamide (2mg) administered twice-daily, in combination with abemaciclib for the first 28 days. No new safety signals were observed for abemaciclib when administered in combination with anastrozole.
Is
general: Yes
