Phase III MONARCH 2 study shows LY 2835219 (abemaciclib) plus fulvestrant improves survival in advanced breast cancer- Eli Lilly

Eli Lilly announced that results from the Phase III MONARCH 2 study showed that LY 2835219 (abemaciclib) in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively). Patients with measureable disease treated with abemaciclib plus fulvestrant achieved an objective response rate (ORR) of 48.1 percent (3.5% complete response [CR]), compared to 21.3 percent (0% CR) in patients treated with fulvestrant alone.

Additionally, abemaciclib plus fulvestrant caused a greater degree of tumor shrinkage than fulvestrant alone. The most frequent adverse events (AEs) of any grade in the abemaciclib plus fulvestrant arm were diarrhea, neutropenia, nausea, and fatigue. Of these, the reported Grade 3 AEs (abemaciclib vs. placebo arm) were diarrhea (13.4% vs. 0.4%), neutropenia (23.6% vs. 1.3%), nausea (2.7% vs. 0.9%), and fatigue (2.7% vs. 0.4%). The data were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published online in the Journal of Clinical Oncology.

Comment: In addition to the ongoing MONARCH trials, including the newly initiated monarchE adjuvant study, which will assess abemaciclib in patients with high-risk, early breast cancer, Lilly is actively evaluating abemaciclib in lung cancer, pancreatic cancer, and patients with brain metastases.