A new phase 3 clinical trial has revealed that the breast cancer therapy known as Abemaciclib, marketed under the brand name Verzenio, significantly improves survival outcomes for patients with early-stage breast cancer. Conducted by Lilly Oncology, the trial demonstrated that Verzenio reduces the risk of relapse in patients with node-positive, hormone receptor-positive (HR+) breast cancer that has spread to the lymph nodes. The results, from a seven-year follow-up, are set to be shared at an upcoming medical meeting, although they have not yet been peer-reviewed.
Jacob Van Naarden, president of Lilly Oncology, emphasized the importance of these findings, 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.” The trial involved 5,637 adults diagnosed with early-stage, HER2-negative, HR+ breast cancer, which is the most common type of breast cancer.
Since its approval by the United States Food and Drug Administration (FDA) in 2017, Verzenio has been a cornerstone in the treatment of breast cancer, primarily when used in conjunction with hormone therapy. In 2022, the medication generated approximately $5.3 billion in sales for Lilly, reflecting its widespread adoption among healthcare providers.
Significant Expansion of Verzenio’s Indications
Initially, Verzenio was authorized for use in advanced or metastatic cases of HR+ breast cancer, which accounts for about 70 to 80 percent of all breast cancer diagnoses. However, in 2023, following a review of early phase clinical trial data, the FDA expanded Verzenio’s indications to include early-stage breast cancer at high risk of recurrence. This decision appears increasingly justified as new data emerges.
Verzenio works by inhibiting enzymes responsible for cell division, thereby preventing the proliferation of cancer cells. When combined with endocrine therapy, which blocks or reduces the impact of certain cancer receptors, the treatment has shown a marked improvement in overall survival rates. Patients receiving the combination therapy for two years demonstrated significantly better outcomes compared to those who underwent hormone therapy alone.
The trial specifically targeted patients diagnosed with HER2-negative, HR+ breast cancer, which is generally more treatable than its aggressive counterpart, triple-negative breast cancer. Despite being more manageable, patients in this trial faced heightened risks due to the spread of cancer to their lymph nodes.
Implications for Future Treatment Protocols
The findings from this trial reinforce the potential of Verzenio in improving patient outcomes. Van Naarden noted, “Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting. Achieving a statistically significant overall survival benefit with just two years of Verzenio therapy reinforces its differentiated profile in high-risk HR+, HER2- early breast cancer.”
With the FDA’s decision to grant Verzenio priority review, it seems clear that the treatment is set to play a pivotal role in the ongoing fight against breast cancer. As further data becomes available, the medical community anticipates a shift in treatment guidelines that could enhance the quality of care for countless patients facing this challenging diagnosis.
