Abemaciclib is the first and only CDK4 and 6 inhibitor in combination with fulvestrant that achieves a statistically significant increase in overall survival in pre, peri and postmenopausal women with advanced breast cancer with HR +, HER2. This has been announced from Eli Lilly and Company, after obtaining the results of the Phase III MONARCH2 clinical trial.
Specifically, MONARCH 2 evaluated abemaciclib in combination with fulvestrant for the treatment of women with advanced or metastatic breast cancer previously treated with endocrine therapy, with positive hormonal receptors (HR +) and human negative epidermal growth factor 2 receptors (HER2-) . The study included both pre and peri and postmenopausal women.
As explained by Anne White, president of Lilly Oncology, “although Abemaciclib has previously shown an impressive benefit in progression-free survival, we are delighted that it is the first and only inhibitor of CDK4 and 6 in combination with fulvestrant capable of significantly increasing global survival in pre, peri and postmenopausal women. ”
Likewise, the MONARCH 2 study also previously demonstrated a statistically significant increase in progression-free survival, the primary objective of the trial that served as the basis for the approval of this regimen in more than 50 countries around the world. On the other hand, no new safety-related data has been observed in the MONARCH 2 analysis, which is consistent with the established safety profile of abemaciclib.
Advanced breast cancer
Advanced breast cancer includes metastatic breast cancer, which means that the cancer has spread from breast tissue to other parts of the body, or local or regionally advanced breast cancer, which means that the cancer has grown outside of the organ where it started but has not yet spread to other parts of the body.
Currently, survival is lower among women with a more advanced stage at the time of diagnosis: the five-year relative survival is 99 percent for localized disease, 85 percent for local or regionally advanced disease, and 27 percent for metastatic disease.