A phase 3 clinical trial has revealed that the oral medication, Verzenio, developed by Lilly Oncology, may significantly enhance survival rates for patients with early-stage breast cancer. This therapy, which contains the active ingredient Abemaciclib, is particularly effective for those diagnosed with high-risk forms of breast cancer that have spread to lymph nodes. The findings come after a seven-year follow-up period, although they have not yet undergone peer review. Lilly has announced plans to present this data at an upcoming medical conference and submit it for formal evaluation.
The president of Lilly Oncology, Jacob Van Naarden, emphasized the importance of these results, stating, “These data validate Verzenio as the standard of care for patients with node-positive, high-risk disease and increase the urgency to ensure all eligible patients are treated.”
Verzenio received approval from the United States Food and Drug Administration (FDA) in 2017, initially targeting advanced or metastatic breast cancer cases that are hormone receptor-positive (HR+). This form of breast cancer accounts for approximately 70 to 80 percent of all cases, wherein the tumor cells have receptors that facilitate growth in response to hormones. The FDA expanded Verzenio’s indications in 2023 to include patients with early-stage breast cancer at high risk for recurrence, suggesting the drug’s effectiveness in broader applications.
After two years of treatment with Verzenio combined with hormone therapy, patients demonstrated a notably improved survival rate compared to those who received hormone therapy alone. The trial involved 5,637 adults suffering from early-stage, HER2-negative, HR+ breast cancer, which is the most prevalent type.
In contrast, triple-negative breast cancer is recognized as the most aggressive variant, characterized by a lack of estrogen, progesterone, and HER2 receptors. The patients in the current study, however, were dealing with a form of breast cancer that had metastasized to lymph nodes, heightening their risk of recurrence.
“Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting,” Van Naarden remarked. He added that achieving a statistically significant overall survival benefit with only two years of Verzenio therapy reinforces its unique position in treating high-risk HR+, HER2- early breast cancer.
The initial success of Verzenio has translated into substantial financial returns for Lilly, with the drug generating approximately $5.3 billion in sales last year. As the pharmaceutical company prepares to share detailed findings from the trial, the implications of these results could reshape treatment protocols for early-stage breast cancer, ultimately improving patient outcomes in a meaningful way.
