FDA Approval Announcement
INDIANAPOLIS, March 3, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence.
High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade: 4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3. This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.
Basis for Indication Expansion
The label expansion is supported by four-year data from the Phase 3 monarchE trial, which evaluated adjuvant Verzenio in combination with ET and showed a deepened benefit in invasive disease-free survival (IDFS) beyond the two-year treatment course with adjuvant Verzenio. The absolute difference in IDFS between treatment groups increased over time, with details as follows:
At four years: 85.5% of patients remained recurrence-free with Verzenio plus ET, compared to 78.6% with ET alone (absolute difference of 6.9%).
At two years: The absolute difference in IDFS between the two groups was 3.1%.
At three years: The absolute difference in IDFS between the two groups was 5.0%.
Risk Reduction: The addition of Verzenio to ET reduced the risk of recurrence by 35% compared to ET alone (HR=0.653 [95% CI: 0.567-0.753]).
Safety: No new safety findings were observed, and overall results are consistent with the well-established safety profile for Verzenio.
These four-year monarchE data were presented at the 2022 San Antonio Breast Cancer Symposium and simultaneously published in The Lancet Oncology.
monarchE Study Details
The monarchE study enrolled 5,637 adults with high-risk HR+, HER2-, node-positive EBC into two cohorts. Verzenio is now approved for use in the full Cohort 1 patient population, which comprised 91% of the study population.
A statistically significant difference in IDFS was observed in the intent-to-treat (ITT) population, primarily due to patients in Cohort 1. As of the data cut-off date:
Overall survival (OS) data remain immature across the entire study.
An OS trend in favor of Verzenio was observed in the Cohort 1 population.
In the Cohort 2 population, more deaths were seen with Verzenio plus ET compared to ET alone (10/253 vs. 5/264).
Expert Statement
"Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer. 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," said Erika P. Hamilton, M.D., medical oncologist, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and an investigator on the monarchE clinical trial. "The initial Verzenio FDA approval in early breast cancer was practice-changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them."
Clinical Background
More than 300,000 people are expected to be diagnosed with breast cancer in the U.S. in 2023.
It is estimated that 90% of all breast cancers are detected at an early stage.
Approximately 70% of all breast cancer cases are the HR+, HER2- subtype.
Although the prognosis for HR+, HER2- EBC is generally favorable, high-risk patients are three times more likely than those with low-risk characteristics to experience recurrence – with the majority being incurable metastatic disease. These patients have an increased risk of recurrence during the first two years of endocrine therapy.
