Halaven(R) is the first single-agent chemotherapy to demonstrate a statistically significant overall survival (OS) benefit in pretreated metastatic breast cancer patients. In a Phase III study (EMBRACE study) conducted overseas in pretreated patients with advanced or recurrent breast cancer, Halaven(R) extended overall survival by 2.7 months compared to Treatment of Physician's Choice (TPC) (os:13.2 months vs. 10.5 months)(os:Hazard Ratio[HR] 0.81)(os:p=0.014). Additionally, a Phase II study (Study 221) conducted in Japan in patients with advanced or recurrent breast cancer patients previously treated with an anthracycline and a taxane showed that Halaven(R) monotherapy demonstrated an excellent antitumor effect as well as a favorable tolerability profile.
Breast cancer remains one of the leading causes of cancer death among women, with approximately 60,000 patients in Japan being affected by the disease each year. Although advances are being made in the treatment of breast cancer in accordance with the development of new anticancer agents, there are still relatively few options available for those patients with inoperable or recurrent disease. The launch of Halaven(R) in Japan means that it will now be possible for inoperable or recurrent breast cancer patients across country to have access to the agent.
Going forward, Eisai seeks to expand the value of Halaven(R) for breast cancer patients globally through the development of additional indications for refractory recurrent or metastatic breast cancer with fewer prior treatments and post-operative adjuvant therapy, as well as a new liposomal formulation. It also plans to develop Halaven(R) as a treatment for other types of cancer such as non-small cell lung cancer, sarcoma, and prostate cancer, which along with the development of its existing pipeline products including MORAb-003 (farletuzumab), a monoclonal antibody targeting ovarian cancer, and E7080 (lenvatinib), a potential treatment for thyroid or endometrial cancer, will enhance the company's portfolio of Women's Oncology products.
In line with its human health care mission (hhc), Eisai's entire force of medical representatives (MRs) will work together to strengthen the company's activities in the Japanese oncology market, thereby contributing to fulfilling the needs of women and families throughout the country living with breast cancer and improving the quality of life.
1. Product Outline
1) Product Name: Halaven(R) Injection 1mg
2) Generic Name: Eribulin mesylate
3) Indications and Usage: Treatment of inoperable or recurrent breast cancer
4) Administration and Dosage: The recommended adult daily dose of eribulin mesylate is 1.4 mg/m2 (body surface area). This dose should be administered intravenously over 2 to 5 minutes once a week for two consecutive weeks of a repeated three-week cycle. Dosage may be reduced according to the patients' condition.
5) Listed Price: Halaven(R) Injection 1 mg 64,070 yen (per 2 ml vial)
6) Packaging: Halaven(R) Injection 1mg: 1 vial
2. About the Global Phase III EMBRACE Study
EMBRACE was an open-label, randomized, multi-center, parallel two-arm study designed to compare overall survival (OS) in patients treated with Halaven(R) versus a Treatment of Physician's Choice (TPC). The study included 762 patients with locally recurrent or metastatic breast cancer who previously had been treated with at least two and a maximum of five prior chemotherapies, including an anthracycline and a taxane. Patients were randomized in a 2:1 ratio to receive either Halaven or TPC. TPC was defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. The vast majority (97%) of patients in the TPC arm received chemotherapy. A protocol prespecified analysis demonstrated that patients treated with Halaven survived a median of 2.5 months longer than patients who received TPC (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio [HR] 0.81; p=0.041).
An updated analysis of overall survival (not protocol prespecified) in the EMBRACE study was performed at the request of European and U.S. regulatory authorities. These results demonstrated an increase of 2.7 months in overall survival for Halaven(R) compared with TPC (OS of 13.2 months versus 10.5 months, respectively; HR 0.81; p=0.014). Data from this analysis was presented at the 33rd Annual San Antonio Breast Cancer Symposium, held in December 2010, and confirmed the overall survival benefits of Halaven(R) as well as no change in safety profile.
The most common adverse reactions (incidence greater than or equal to 25%) among patients treated with Halaven(R) were asthenia (fatigue), neutropenia, anemia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms, legs and other parts of the body), nausea and constipation. The most common serious side effects reported in patients receiving Halaven were neutropenia with or without fever (4% and 2%, respectively). The most common adverse reaction resulting in discontinuation of treatment with Halaven(R) was peripheral neuropathy (5%).
3. About the Phase II Study (Study 221) Conducted in Japan
Study 221 was a multicenter, open-label trial conducted in advanced or recurrent breast cancer patients previously treated with an anthracycline and a taxane. The study demonstrated a high response rate of 21.3% (response observed in 17 out of 80 evaluable patients), and showed that eribulin has a favorable tolerability profile.
