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Addition of abemaciclib to fulvestrant improves PFS in advanced breast cancer
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The addition of abemaciclib to fulvestrant significantly extended PFS among certain women with advanced breast cancer, according to the drug’s manufacturer.
Abemaciclib (LY2835219, Eli Lilly) is a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor.
The phase 3 MONARCH 2 trial included 669 women with hormone receptor–positive, HER-2–negative advanced breast cancer. All women progressed on or within 2 months of endocrine therapy receipt in the neoadjuvant or adjuvant setting, or while undergoing first-line endocrine therapy for metastatic disease.
Researchers excluded women who underwent chemotherapy in the metastatic setting.
Investigators randomly assigned women to fulvestrant (Faslodex, AstraZeneca) — which blocks ER function by inducing ER degradation — plus twice-daily oral abemaciclib or placebo. Treatment continued until disease progression.
Results showed the addition of abemaciclib to fulvestrant significantly extended PFS, the study’s primary endpoint.
Abemaciclib exhibited a safety profile consistent with that observed in prior studies. The most common adverse events included diarrhea, neutropenia, nausea and fatigue.
Detailed efficacy and safety results will be presented at an upcoming medical meeting.
“We are excited about the outcome of our first phase 3 study for abemaciclib,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Eli Lilly Oncology, said in a company-issued press release. “These data are an important milestone in our goal of bringing abemaciclib to patients with advanced breast cancer, and we look forward to our upcoming conversations with regulators.”
Eli Lilly intends to submit a new drug application in the second quarter of this year for single-agent abemaciclib based on results of the MONARCH 1 study, designed to evaluate the drug in patients with refractory metastatic breast cancer whose disease progressed following multiple prior treatments. The company intends to submit a new drug application based on the MONARCH-2 data in the third quarter of this year.
Eli Lilly is conducting two additional studies of abemaciclib for the treatment of breast cancer.
The phase 3 MONARCH 3 trial is designed to evaluate abemaciclib in combination with a nonsteroidal aromatase inhibitor in patients with hormone receptor–positive, HER-2–negative advanced breast cancer. The phase 2 monarcHER trial is designed to evaluate the combination of abemaciclib plus trastuzumab (Herceptin, Genentech) in women with hormone receptor–positive, HER-2–positive locally advanced or metastatic breast cancer.