'Lilly's Verzenio, a complete cure option for recurrent breast cancer patients'

Lilly Korea's CDK4/6 inhibitor Verzenio (ingredient: abemaciclib) will be an alternative treatment for the complete recovery of early breast cancer patients with a high risk of recurrence, the company said Wednesday.

In November, Lilly Korea obtained expanded indication approval from the Ministry of Food and Drug Safety for using Verzenio as an adjuvant treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) lymph node-positive high-risk early breast cancer.

Accordingly, hospitals can use the treatment combined with endocrine therapy as adjuvant therapy after surgery for adult patients with early breast cancer with a high risk of positive lymph node recurrence.

During a news conference celebrating the expanded indication of Verzenio, a medical expert agreed that the expanded indication for Verzenio will significantly help improve outcomes of HR+ and HER2- early breast cancer patients.

"Although early breast cancer of the HR+/HER2- type generally has a positive prognosis, about one in five patients who have received adjuvant endocrine therapy experience a recurrence," Professor Sohn Joo-hyuk of the Department of Oncology at Severance Hospital said. "In such cases, distant metastasis, cancer that has spread from the original tumor to other organs, may occur and lowers the patient's survival rate."

Therefore, Verzenio's expanded indication will become a standard therapy for patients with recurrent, high-risk early breast cancer, Sohn added.

Sohn also explained the significance of the monarchE clinical trial, which led to the expanded indication of Verzenio.

"Despite more than two decades of various studies for using an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy, Verzenio's monarchE clinical trial is the only study that showed a successful outcome," Sohn said. "Verzenio and endocrine therapy combination treatment compared to endocrine therapy alone reduced the risk of recurrence through the invasive disease-free survival (IDFS) and distant relapse-free survival (DRFSl) index."

He added that the study also confirmed the results of reducing the risk of recurrence.

Sohn also introduced the four-year update data of monarchE, which was recently announced at the 2022 San Antonio Breast Cancer Symposium annual conference, held from last Tuesday to Saturday.

In the entire patient group, the data confirmed that Verzenio and endocrine therapy reduced the risk of recurrence by about 34 percent compared to endocrine therapy alone and also reduced the risk of distant metastasis by about 34 percent.

In addition, IDFS at four years was 85.8 percent in the Verzenio and endocrine therapy combination group and 79.4 percent in the endocrine therapy alone group, showing a difference of 6.4 percentage points, compared to 2.8 percentage points difference at two years.

"Looking at the four-year data, the IDFS rate shows that the difference between the combination therapy group and the monotherapy group continues to widen," Son said. "As the treatment continues to show statistical significance, I expect it to become a standard treatment in the future."

Sohn stressed that he hopes the new indication for Verzenio will receive reimbursement so more breast cancer patients can benefit from treatment.

A Lilly official stressed that as there is unmet demand, the company believes that the possibility of receiving reimbursement is sufficient.

"We believe that the U.K.'s reimbursement discussions last June will have a positive impact," the Lilly official said. "We will prepare various data such as cost-effectiveness and do our best to achieve good results through communication with the Korean health authorities."