A new phase 3 clinical trial has revealed promising results for the treatment of early-stage breast cancer. The drug, Abemaciclib, marketed under the brand name Verzenio, has been shown to significantly enhance survival rates for patients with early-stage, node-positive breast cancer. The findings were announced by Lilly Oncology, although they have yet to undergo peer review. The company plans to present the data at an upcoming medical conference and submit it for official review.
Trial Results and Implications
According to Jacob Van Naarden, president of Lilly Oncology, “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.” The trial involved 5,637 adults diagnosed with early-stage, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive (HR+) breast cancer. This type of cancer is the most prevalent, accounting for approximately 70% to 80% of all breast cancer cases.
Verzenio, which gained approval from the United States Food and Drug Administration (FDA) in 2017, has been recognized for its effectiveness in treating advanced breast cancer. In 2022, the drug generated approximately $5.3 billion in sales for Lilly. Initially, it was approved for hormone receptor-positive metastatic breast cancer. However, in 2023, the FDA expanded its use to include patients in the early stages of the disease who are at high risk of recurrence.
The trial results suggest that Verzenio, when combined with hormone therapy, significantly improves overall survival compared to hormone therapy alone. This combination therapy works by inhibiting the enzymes responsible for cell division while also blocking cancer receptors through endocrine therapy.
Future Directions
Van Naarden emphasized the importance of preventing disease relapse, stating, “Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting.” The trial’s results indicate that the addition of Verzenio to treatment regimens can provide a statistically significant survival advantage for patients.
As the medical community awaits peer review, the FDA’s decision to grant priority review for Verzenio appears increasingly justified. The new data reinforces the drug’s potential as a cornerstone in the treatment of high-risk HR+, HER2-negative early breast cancer.
With ongoing efforts to improve patient outcomes, the results of this trial may lead to broader access to effective therapies for those diagnosed with this challenging disease. As healthcare providers look to implement the latest findings, the urgency to treat eligible patients with the best available options continues to grow.
