Lilly stated that abemaciclib in combination with fulvestrant was demonstrated to be superior to fulvestrant plus placebo, with the former showing statistically significant improvement in PFS in comparison.
The trial, dubbed MONARCH 2, was carried out in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer whose disease had relapsed or progressed post endocrine therapy.
Lilly Oncology global development and medical affairs senior vice president Levi Garraway 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 trial was a double-blind study held globally in 669 patients who were randomized to either abemaciclib or placebo given orally two times a day, both in combination with fulvestrant at its approved dose and schedule, until the progression of the disease.
As per Lilly, the enrolled patients had experienced disease progression at 12 months or earlier after getting endocrine treatment in the neoadjuvant or adjuvant setting or while being administered with first-line endocrine treatment for metastatic disease.
Abemaciclib, as per Lilly, specifically inhibits the CDK 4 and CDK 6 cyclin-dependent kinases whose increased signaling causes uncontrolled cell growth in many cancers.
The MONARCH 2 trial omitted patients who had undergone chemotherapy in the metastatic setting.
In the second quarter, Lilly plans to file a new drug application (NDA) for single-agent abemaciclib based on the MONARCH 1 study.
The NDA will be submitted for the drug’s treatment in refractory metastatic breast cancer patients who had experienced disease progression after multiple prior treatments like endocrine therapy and one to two chemotherapy regimens in the metastatic setting.
The company intends to file an additional application for MONARCH 2 in the third quarter of this year.