Verzenio expects to address the unmet demand

for breast cancer

Lilly Korea holds a meeting to commemorate the expansion of the indication

A 4-year monarchE study confirmed a reduction in the risk of death

Professor Son Joo-hyuk

Expectations are high for securing early breast cancer indications for Verzenio, a breast cancer treatment with CDK4/600 inhibition mechanism.

 

Lilly Korea held a press conference on the 14th to commemorate the expansion of permission for early breast cancer indications at high risk of recurrence of the anticancer drug Verzenio.

 

Verzenio obtained approval from the Ministry of Food and Drug Safety on the 18th of last month as a treatment used in combination with hormone receptor-positive, human epithelial cell growth factor 2 negative (HR+/HER2-), early breast cancer adult patients at high risk of recurrence of lymph node-positive, and endocrine therapy.

 

Verzenio's approval is meaningful in that the first CDK 4&6 inhibitor for early breast cancer patients at high risk of HR+/HER2-lymph node-positive recurrence was introduced in Korea.

 

Sohn Joo-hyuk, a professor of oncology at Severance Hospital, shared the medical unfulfilled needs of HR+/HER2-lymph node-positive recurrence early breast cancer patients and the clinical value of Verzenio confirmed through the monarch clinical study, which was the background of approval of MFDS.

 

In the first topic of the presentation, "HR+/HER2-High-Risk Early Breast Cancer Patients' Medical Unfulfilled Demand," Professor Sohn said, "Most of the female cancers in Korea are diagnosed early due to screening activation, especially in the standard treatment of HR+/HER2- patients, to prevent recurrence after surgery.

 

He added, "The prognosis of HR+/HER2-early breast cancer is generally known to be good, but high-risk patients are highly likely to recur, making it difficult to expect long-term survival." According to domestic statistics, the survival rate of general early breast cancer patients is more than 90%, which is higher than that of other diseases.

 

However, patients with recurrence risk factors such as lymph node-positive, high tumor grade, large tumor size, and fast cell proliferation are known to have a higher risk of remote recurrence and death than general patients.

 

Studies have shown that if the tumor size exceeds 5cm, the 5-year survival rate of breast cancer patients decreases from 57% (without lymph node metastasis) to 21% (with lymph node metastasis).

 

Professor Son said, "The recurrence of early breast cancer patients after the first treatment is usually one to two years, and more effective postoperative auxiliary treatment is needed to reduce the risk of recurrence and death." However, since the introduction of aromatase inhibitors in the early 2000s, the absence of new treatment options for HR+/HER2-early breast cancer patients has led to a medical non-fulfillment demand." Verzenio's monarch clinical trial is the only study that has confirmed successful results in about 20 years as a combination of endocrine therapy as an adjunct treatment for HR+/HER2-early breast cancer.

 

In monarch cohort 1, which served as the basis for this indication expansion permit, Verzenio+ endocrine therapy confirmed remote recurrence risk reduction results through Distance Relapse-Free Survival (DRF) indicators as well as Invisible Disease-Free Survival (IDFS) indicators compared to endocrine therapy alone.