Lilly to continue trial of abemaciclib and fulvestrant combo for breast cancer

Following interim analysis, a DMC recommends the study to continue without modification.

"We had stringent criteria set for this interim analysis and we look forward to receiving the final MONARCH 2 results in the first half of 2017," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology. "We remain optimistic that treatment with abemaciclib, in combination with fulvestrant could offer improved outcomes for patients."

The Phase III, double-blind study, designed to evaluate the safety and efficacy of abemaciclib in combination with fulvestrant, was conducted across 142 sites worldwide. The intent-to-treat population of 669 patients was randomized to receive abemaciclib or placebo orally every 12 hours on a continuous dosing schedule, given in combination with fulvestrant at the 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 for the study. The primary endpoint for MONARCH 2 is progression-free survival (PFS).

The trial will continue into the first half of 2017 and will include a final analysis of PFS, overall survival and safety data.

Lilly will await further data and continue to work with the FDA to inform its submission plan for single-agent abemaciclib, based on the MONARCH 1 study. This Phase II study evaluated the single-agent activity and safety of abemaciclib in patients with refractory metastatic breast cancer, whose disease had progressed following multiple prior treatments, including chemotherapy.