Indianapolis-based Lilly has reported that its breast cancer drug, abemaciclib, in combination with fulvestrant, has yielded positive results by meeting its primary endpoint, progression-free survival (PFS) in a phase 3 breast cancer trial.
The combination of Lilly breast cancer drug abemaciclib with fulvestrant was proved to be more effective than the fulvestrant plus placebo combination in the phase 3 trial named MONARCH 2. Abemaciclib’s combination with fulvestrant recorded statistically noteworthy improvement in PFS in comparison with the placebo arm.
Lilly’s breast cancer drug trial, MONARCH 2 featured women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who had the cancer relapsed or in progressed state after undergoing endocrine therapy.
Levi Garraway, Global Development and Medical Affairs Senior Vice President at Lilly Oncology commenting on the results of the breast cancer drug trial said: “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.
“This is another example of Lilly’s commitment to delivering breakthrough treatments and improving outcomes for patients with cancer.”
The phase 3 breast cancer trial was a double-blind study carried out at various centres across the world in 669 patients randomized to be orally subjected to either abemaciclib or placebo two times a day. Both abemaciclib and placebo were given in combination with fulvestrant at its approved dose and schedule, until the patient’s breast cancer had progressed.
Lilly revealed that the enrolled breast cancer patients had recorded progression in their disease in 12 months or before. This was after they had received endocrine treatment in the neoadjuvant or adjuvant setting or while being subjected to first-line endocrine therapy for metastatic breast cancer.
Lilly’s breast cancer drug, abemaciclib has been developed to specifically inhibit the CDK 4 and CDK 6 cyclin-dependent kinases that are regarded to be the cause of uncontrolled cell growth in several cancers through their increased signalling.
The pharma’s phase 3 breast cancer trial excluded patients who had received chemotherapy in the metastatic setting.
Lilly plans to submit a new drug application (NDA) in Q2 2017 for single-agent abemaciclib based on the results of its MONARCH 1 study.
The application will be filed for the abemaciclib’s indication in refractory metastatic breast cancer patients whose disease had progressed following multiple prior treatments including endocrine therapy and one or two chemotherapy regimens given in the metastatic setting.
Based on the data of the phase 3 breast cancer trial, MONARCH 2, Lilly plans to file an additional application for its breast cancer drug abemaciclib in Q3 2017.