Eli Lilly demonstrates Verzenio win in high-risk breast cancer subset at ASCO

Eli Lilly has presented data for the potential new use of its CDK4/6 inhibitor Verzenio in high-risk early breast cancer patients at the 2021 American Society of Clinical Oncology (ASC) annual meeting.

An exploratory analysis of a prespecified subgroup of patients with HR-positive/HER2-negative high-risk early breast cancer who had received neoadjuvant chemotherapy showed that the addition of Verzenio (abemaciclib) to endocrine therapy (ET) decreased the risk of breast cancer recurrence in these patients by 38.6% compared to ET alone.

Verzenio plus ET also reduced the risk of patients developing metastatic disease by 39%, corresponding to a 6.7% difference in two-year distant relapse-free survival (DRFS) rates between the Verzenio treatment and control arms.

"People who receive neoadjuvant chemotherapy typically represent a patient population with a substantial risk of breast cancer recurrence. The data from monarchE further confirms this higher risk based on the number of events that occurred in the control arm for this subset of patients," said Maura Dickler, distinguished medical fellow, Lilly Oncology.

"Given the need for new treatments for high-risk early breast cancer, especially in this neoadjuvant population, it's encouraging to see these impressive results with a 38%  reduction in the risk of recurrence with the addition of Verzenio to standard endocrine therapy,” she added.

Previously, Lilly reported initial results from the monarchE trial, which showed that the Verzenio/ET combination reduced the risk of developing metastatic disease by 28 %, with the largest reductions occurring in rates of metastases to the liver and bone.

The two-year distant relapse-free survival rate was 93.6% in the Verzenio arm versus 90.3% in the control arm at the time of the initial analysis, compared to 89.5% in the Verzenio arm versus 82.8% in the ET only control arm at the time of the most recent analysis.

The monarchE trial is still ongoing, with patients continuing to be followed to assess the safety, overall survival and patient reported outcomes associated with Verzenio plus ET in high-risk early breast cancer patients.

Lilly also recently initiated a phase 3 trial – eMonarcHER – of Verzenio in combination with ET in patients with HR-positive/HER2-negative, node-positive, high-risk early breast cancer receiving adjuvant ET after completing surgery and neoadjuvant and/or adjuvant HER2 targeted therapy.