A breakthrough therapy for advanced breast cancer also works well in the early stages, allegedly improving survival outcomes for patients.
According to the pharmaceutical company Lilly Oncology, a phase 3 clinical trial has now confirmed that the Abemaciclib pill, sold under the brand name Verzenio, can significantly reduce the risk of relapse in some types of early breast cancer, which had spread to the lymph node.
Results from the seven-year follow-up are not yet peer-reviewed; however, the company promises to share the data at an upcoming medical meeting and submit a paper for peer review.
“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,” says Jacob Van Naarden, president of Lilly Oncology.
Related: Breakthrough: New Drug Could Halt The Growth of Aggressive Breast Cancer
Since Verzenio’s approval by the United States Food and Drug Administration (FDA) in 2017, this oral pill has proven an effective breast cancer therapy, used in combination with hormone therapy.
Last year alone, it brought the company $5.3 billion in sales.
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Verzenio was initially approved for advanced or metastatic breast cancer cases that are hormone receptor-positive (HR+). With this type of cancer, which encompasses about 70 percent to 80 percent of all breast cancer cases, the tumor cells have receptors that interact with hormones in order to grow.
In 2023, after reviewing data from early phase clinical trials, the FDA expanded Verzenio’s use to early stages of breast cancer at high risk of recurrence. Years later, that decision appears more justified than ever.
Verzenio works in conjunction with hormone therapy to prevent breast cancer cells from proliferating. Endocrine therapy blocks or reduces the impact of some cancer receptors, while Verzenio inhibits enzymes responsible for cell division.
After two years of Verzenio and hormone therapy combined, the overall survival of patients with breast cancer was significantly improved compared to the hormone therapy on its own.
The trial involved 5,637 adults in the early stages of HER2-negative, HR+ breast cancer, which is the most common type.
Triple-negative breast cancer is the most aggressive type, with cells that lack estrogen receptors, progesterone receptors, and HER2 receptors.
In comparison, HER2-negative, HR+ breast cancers are highly treatable, and yet patients in the current trial had cancer that had spread to the lymph nodes, increasing the risk of recurrence.
“Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting,” says Van Naarden.
“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.”
The FDA seems to have made a wise choice when it granted the medicine priority review.
