The progression-free survival doubles! Lilly announces the latest data on new breast cancer drugs

The progression-free survival doubles! Lilly announces the latest data on new breast cancer drugs

April 19, 2018 Source: WuXi PharmaTech

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Eli Lilly recently published the final data of the third phase clinical trial of MONARCH3, a new breast cancer drug, Verzenio (abemaciclib), and received the latest FDA approval to treat some breast cancer patients.

Breast cancer is the most common female cancer in the world. About 30% of early breast cancer patients in the United States have metastases, and it is estimated that approximately 6-10% of breast cancer patients have metastasized at the time of initial diagnosis. The survival rate of patients with metastatic breast cancer is significantly lower than that of patients with early breast cancer. The 5-year survival rate of patients with early breast cancer is 99%, and the 5-year survival rate for patients with metastatic breast cancer is 26%. Therefore, developing innovative therapies for advanced breast cancer is critical to saving patients' lives.

Abemaciclib, developed by Eli Lilly and Company, is an inhibitor of oral cyclin-dependent kinase (CDK) 4 and 6. In hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer cells, CDK4 and CDK6 promote phosphorylation of retinoblastoma protein (Rb) and promote cell cycle Advance and cell proliferation. Abemaciclib is able to inhibit phosphorylation of Rb and block cells from the G1 phase to the S phase of the cell cycle, leading to cell senescence and apoptosis.

The data released at the annual meeting of the American Association for Cancer Research (AACR) shows that abemaciclib provides a longer progression-free survival (PFS) than previously. Last year's MONARCH 3 interim data released by Lilly showed that the PFS is estimated to be 14 months. This data shows that abemaciclib combined with aromatase inhibitor (AI) provides a 28-month PFS.

The FDA approved abemaciclib for the treatment of postmenopausal women with HR+, HER2-advanced or metastatic breast cancer earlier this year. Studies have shown that adding abemaciclib to endocrine therapy can prolong PFS in patients. Among the patients with observable disease, the objective response rate was 55.4% in the abemaciclib group and 40.2% in the placebo group. In addition, in a subgroup of MONARCH 2 and MONARCH 3 clinical trials, Lilly's researchers identified clinical disease characteristics that have an unfavorable prognosis, and believe that this information can help clinicians optimize through the use of CDK4 and 6 inhibitors. Treatment decisions also provide the basis for personalized medicine.

"The significant extension of progression-free survival is critical to the lives of patients. We are pleased with this news that gives breast cancer patients more choices." Dr. Levi Garraway, Senior Vice President, Global Development and Medical Affairs, Lilly, said: "Doctors We have seen some positive effects and have increased confidence in using abemaciclib."

With the success of abemaciclib, Lilly's current goal is to determine if it can be used for other types of breast cancer and other cancer indications. Currently, the company has begun research on the use of abemaciclib as adjunctive therapy for high-risk breast cancer, as well as a phase 2 study in HER2+ breast cancer, with mid-term trial data expected to be available by the end of the year.

We expect this new drug for breast cancer to bring more treatment options to a large number of female patients with breast cancer.

Reference materials:

[1] Eli Lilly Shows Off More Verzenio Data at AACR

[2] WuXi PharmaTech - First Line Therapy! Lilly Breast Cancer New Drugs Approved by FDA

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