Eli Lilly and Company announced that Verzenio, in combination with standard adjuvant endocrine therapy, significantly decreased the risk of breast cancer recurrence by 25 percent compared to standard adjuvant ET alone for people with HR+, HER2- high risk early breast cancer.
The findings — presented at the the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress — were based on the results of the monarchE Phase 3 trial, which randomized 5,637 patients with HR+, HER2- high risk early breast cancer from more than 600 sites in 38 countries
The lead investigator for the monarchE trial, Stephen Johnston, M.D., Ph.D., called the findings "potentially one of the most notable treatment advances in the last two decades for this population of breast cancer patients."
In Sept 2017, the FDA approved Verzenio, a CDK 4/6 inhibitor, for the treatment of certain advanced or metastatic breast cancers, but the new findings could lead to a new treatment option for people with high risk early breast cancer living with concerns of recurrence. The drug is Lilly's first solid oral dosage form to be made using continuous manufacturing.
Verzenio (in combination with endocrine therapy) is the only CDK4 & 6 inhibitor to demonstrate a statistically significant improvement in invasive disease-free survival (IDFS) in early breast cancer — succeeding where Pfizer's Ibrance did not.
Read the press release
