Eisai Launches Halaven® (Eribulin Mesylate) in China for Locally Advanced or Metastatic Breast Cancer

Tokyo, January 13, 2020 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; hereinafter referred to as “Eisai”) announced that Halaven®, the latest generation of chemotherapy drug originally developed by Eisai, has entered the Chinese market (generic name: eribulin mesylate).

Halaven® is a soft sponge-derived microtubule dynamics inhibitor with unique binding properties. In addition to its mechanism of action involving the inhibition of microtubule dynamics, non-clinical studies have demonstrated that Halaven® has unique effects on the tumor microenvironment, such as promoting vascular remodeling in the tumor core.^[1]Promotes epithelial state transition and reduces the migratory capacity of breast cancer cells.^[2]In a Phase III clinical study (EMBRACE) involving 762 patients with advanced or recurrent breast cancer who had previously received anthracycline and taxane therapy, treatment with Halaven® was compared with physician’s choice of therapy. The results demonstrated that the Halaven® group achieved higher overall survival.^[3]The most common adverse events (incidence rate of 25% or higher) in the Halaven® group were fatigue, neutropenia, alopecia, peripheral neuropathy, nausea, and constipation. Halaven® has been approved in more than 70 countries worldwide for the treatment of breast cancer and has become a standard regimen for advanced breast cancer treatment in major countries across the United States, Europe, and Asia.

In China, Halaven® was approved as a new drug for the treatment of patients with locally advanced or metastatic breast cancer, based on Study 304.^[4]As a result, in this Phase III clinical study involving 530 patients with locally recurrent or metastatic breast cancer who had previously received at least two chemotherapy regimens containing anthracyclines and taxanes, treatment with Halaven® significantly prolonged progression-free survival compared with the control treatment, vinorelbine, with statistical significance. The five most common adverse events observed in the Halaven® group in this study were decreased white blood cell count, decreased neutrophil count, increased aspartate aminotransferase, increased alanine aminotransferase, and anemia.

Breast cancer is currently the most common cancer among Chinese women. In recent years, the number of new breast cancer cases in China has been increasing year by year,^[5]In 2018, there were an estimated 37,000 new cases of breast cancer, with over 100,000 patients dying from tumor-related factors.^[6]

Eisai positions oncology as a key therapeutic area, aiming to discover revolutionary new drugs with the potential to cure cancer. Lenvima® was approved in China in November 2018 for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.* With the approval of Lenvima®, Eisai is committed to further meeting the diverse needs of cancer patients, their families, and healthcare institutions in China, and to contributing to the enhancement of patient well-being.

*Eisai and Merck & Co.’s Chinese subsidiary, “Merck China,” have been providing information about Lenvima® in China.

About Halaven® (generic name: eribulin mesylate)

Halaven® is a microtubule dynamics inhibitor of the halichondrin class, featuring a novel mechanism of action. Structurally, Halaven® is a simplified, synthetically produced analog of halichondrin B, a natural product isolated from the marine sponge *Lissodendoryx* (formerly *Halichondria*) okadai. Halaven® is believed to exert its effect by inhibiting the growth phase of microtubule dynamics, thereby preventing cell division. In addition to its mechanism of inhibiting microtubule dynamic growth, non-clinical studies have demonstrated that Halaven® has unique effects on the tumor microenvironment, such as increasing vascular perfusion and permeability in the tumor core.^[3], promoting epithelial state changes and reducing the metastatic potential of breast cancer cells^[4]etc.

Halaven® was first approved in the United States in November 2010 for the treatment of patients with metastatic breast cancer. Halaven® has currently been approved in more than 70 countries worldwide for the treatment of breast cancer, including Japan, China, and countries in Europe, the Americas, and Asia. In addition, Halaven® was first approved in the United States in January 2016 as a treatment for soft tissue sarcoma and has received approval in more than 60 countries, including Japan, European nations, and Asian countries. Furthermore, Halaven® has been designated as an orphan drug for soft tissue sarcoma in both the United States and Japan.

Specifically, Halaven® has been approved for the following indications.

In the United States, it is used to treat the following patients:

In Japan, indicated for the treatment of the following patients:

In Europe, it is used for the treatment of the following adult patients:

[1] Funahashi Y et al., Eribulin mesylate reduces abnormalities in the tumor microenvironment via vascular remodeling in preclinical human breast cancer models. Cancer Science, 2014; 105, 1334-1342

[2] Yoshida T et al., Eribulin inhibits experimental metastasis of breast cancer cells by reversing the phenotype from “epithelial-mesenchymal transition” (EMT) to “mesenchymal-epithelial transition” (MET) state. British Journal of Cancer, 2014; 110, 1497-1505

[3] Cortes J et al., Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3, open-label, randomised study, The Lancet, 2011; 377, 914-23

[4] Yuan P et al., Comparison of eribulin and vinorelbine in women with locally recurrent or metastatic breast cancer: a randomized clinical trial, European Journal of Cancer, 2019; 112, 57-65

[5] Lei F et al., Breast cancer in China. Lancet Oncology, 2014; 15(7), e279-e289

[6] Ferlay J, et al., (2018). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer.https://gco.iarc.fr/today, as of January 10, 2020