This article has been updated to correctly note that there was a 6.9 percent absolute difference in invasive disease-free survival between the two arms in the monarchE trial at four years.
NEW YORK – Eli Lilly announced on Friday that the US Food and Drug Administration has expanded the group of breast cancer patients who are eligible for its CDK4/6 inhibitor Verzenio (abemaciclib).
The agency approved Verzenio in combination with endocrine therapy as an adjuvant treatment for patients with hormone receptor (HR)-positive HER2-negative early-stage breast cancer that has spread to the lymph nodes. Patients must be at high risk of recurrence based on nodal status, tumor size, and tumor grade in order for patients to receive the treatment for early-stage disease.
The FDA originally approved Verzenio in combination with endocrine therapy as an adjuvant treatment in this setting in 2021, and at that time, patients also had to have a Ki-67 score of at least 20 percent. With the latest approval, patients no longer must have this Ki-67 score in order to receive the drug.
The earlier and most recent approval are supported by data from the 5,600-patient monarchE trial, though the latest labeling update is based on longer follow-up data. The updated analysis at four years showed 85.5 percent of patients were recurrence free on Verzenio plus endocrine therapy compared to 78.6 percent of patients on endocrine therapy alone — a 6.9 percent absolute difference in invasive disease-free survival between the two arms. By comparison, at two and three years, the absolute difference in invasive disease-free survival between these arms was 3.1 percent and 5 percent, respectively.
The combination regimen also reduced patients' risk of recurrence by 35 percent compared to just endocrine therapy.
Erika Hamilton, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and a monarchE investigator, said that the initial FDA approval of Verzenio was "practice changing," and with this expanded indication many more early-stage breast cancer patients will have the opportunity to receive the CDK4/6 inhibitor. "Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer," Hamilton said in a statement. "The magnitude of benefit seen in the four-year data from the monarchE study reinforces my confidence in adjuvant Verzenio as the standard of care for high-risk patients in this setting."
Out of an estimated 300,000 breast cancer patients diagnosed in the US this year, 90 percent will be diagnosed with early-stage disease and 70 percent have HR-positive HER2-negative tumors. Patients with high-risk clinical features are three times more likely to experience disease recurrence than low-risk patients, particularly in the first two years following adjuvant treatment with just endocrine therapy.