In a Phase III study, Eli Lilly’s Verzenio combined with standard adjuvant endocrine therapy met its primary endpoint of invasive disease-free survival in high-risk breast cancer and significantly reduced the risk of a recurrence of the disease.
In a Phase III study, Eli Lilly’s Verzenio (abemaciclib) combined with standard adjuvant endocrine therapy met its primary endpoint of invasive disease-free survival (IDFS) in high-risk breast cancer and significantly reduced the risk of a recurrence of the disease.
The results announced this morning are from a planned interim analysis of the Phase III monarchE study. Not only did data show a reduction in the risk of recurrence in patients with high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer, Verzenio and standard endocrine therapy also reduced the risk of death in these patients. Verzenio is the only CDK4 & 6 inhibitor to demonstrate statistically significant improvement in invasive disease-free survival in this setting, the company said.
The monarchE study included 5,637 patients with high risk, node positive, HR+, HER2- early breast cancer. Patients were randomized one-to-one to receive Verzenio plus standard adjuvant endocrine therapy or standard adjuvant endocrine therapy alone. Secondary trial objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. The monarchE trial will continue through the completion date, estimated for June 2027. At the time of the interim analysis, the IDFS results are considered definitive. All patients on the monarchE trial will be followed until primary analysis and beyond to assess overall survival and other endpoints. Full data from the monarchE study is expected to be presented at a future medical conference.
Maura Dickler, vice president of late-phase development in oncology at Lilly Oncology, said the goal of high risk early-stage breast cancer patients is to prevent a recurrence of the disease. It is estimated that approximately 30% of people diagnosed with HR+, HER2- early breast cancer, the most common type of breast cancer, are at risk of their cancer returning. This risk of recurrence increases based on certain clinical and/or pathological features such as breast cancer that has spread to the lymph nodes, a larger tumor size and a higher tumor grade.
“monarchE was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high-risk HR+, HER2- early breast cancer,” Dickler said in a statement.
Eli Lilly said it intends to take the results from the monarchE study to the U.S. Food and Drug Administration and other regulatory agencies for the possible approval of a new indication for Verzenio, which was originally approved in 2017 for the treatment of advanced breast cancer.
Anne White, president of Lilly Oncology, said the fact the results from the study were seen so quickly during the interim analysis is exciting because of the potential of the drug in helping patients with this type of breast cancer.
“Verzenio in combination with endocrine therapy has demonstrated positive results in people with high-risk HR+, HER2- early breast cancer – a major milestone with the potential to change the paradigm of how early breast cancer is treated and a first for the CDK4 & 6 inhibitor class. The fact that these results were achieved early, at the interim analysis, is also exciting because it will help us speed this innovation to people who need it. We look forward to submitting these data to regulatory authorities before the end of 2020,” White said.
