LGBT Cancer Project

Breast Cancer - HER2 Positive

October 16, 2017

Eli Lilly reported that interim results from the double-blind, placebo-controlled, phase III MONARCH 3 study evaluating Verzenio (abemaciclib) in combination with a nonsteroidal aromatase inhibitor (NSAI) (anastrozole or letrozole) for progression-free survival (PFS) and objective response rate (ORR) compared to an NSAI alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. A total of 493 patients were randomized 2:1 to receive 150mg of abemaciclib or placebo orally twice a day, without interruption, given in combination with either 1mg of anastrozole or 2.5mg of letrozole once daily until disease progression or unacceptable toxicity. MONARCH 3 met a rigorous threshold for demonstrating efficacy at the time of pre-planned interim analysis with a 46% reduction in the risk of progression or death in patients receiving initial therapy for metastatic disease. The median PFS for abemaciclib in combination with an NSAI was not reached (i.e., the disease had not progressed significantly), compared to 14.7 months in the placebo arm (HR: 0.54; 95% CI: 0.41-0.72; p=0.000021). These results are supported by an improvement in response rate, with a 59.2% ORR in patients with measurable disease, including five patients (1.5%) achieving a complete response. Median duration of response (DoR) was not reached in the abemaciclib-plus-NSAI arm. In MONARCH 3, abemaciclib in combination with an NSAI was generally well-tolerated.

March 27, 2017

Eli Lilly issued results of a phase III trial of abemaciclib in combination with fulvestrant 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. The global, double-blind study had an intent-to-treat population of 669 patients 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 for the study. The most common adverse events observed were diarrhea, neutropenia, nausea and fatigue, and were consistent with the previous studies of abemaciclib. Lilly intends to submit a new drug application (NDA) for single-agent abemaciclib in the second quarter of 2017.