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Additional analysis of phase III erebulin study released

Eisai Co., Ltd. announced today that the results of an additional analysis of a Phase III clinical study (Study 309) of eribulin, marketed as Halaven, in patients with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma).

The study was presented by Dr. Patrick Schoffski of University Hospitals Leuven, Belgium, at a plenary session of the 14th Japanese Society of Medical Oncology (JSMO) Annual Meeting held in Kobe from July 28 to 30, 2016.

Study 309 was a Phase III clinical study which examined the efficacy and safety of eribulin versus dacarbazine in 452 patients aged 18 years and older with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies (including an anthracycline and at least one other additional regimen).

Approximately 12,000 patients in the United States and 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year.

According to a patient survey conducted by Japan's Ministry of Health, Labour and Welfare, there are approximately 4,000 patients with soft tissue sarcoma in Japan.

While treatment of soft tissue sarcoma is focused on curative surgery, if the degree of malignancy is high, treatment then becomes a combination of chemotherapy and radiation therapy.

As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

According to the results of preplanned subgroup analyses of the duration of response in patients with liposarcoma and leiomyosarcoma, median duration of response for the eribulin treatment was 12.5 months [95% CI: 1.7-Not Estimable] and median duration of response for dacarbazine treatment was 4.2 months [95% CI: 2.2-14.7].

Furthermore, as part of an additional analysis, patients with liposarcoma in Study 309 were categorised by three subtypes, dedifferentiated liposarcoma, myxoid/round liposarcoma and pleomorphic liposarcoma, and additional analyses were carried out on each subtype.

According to the results of these analyses, eribulin demonstrated a trend for extension in overall survival over dacarbazine in each subtype.

In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with eribulin were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which is consistent with the known side-effect profile of eribulin.

Eribulin is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action.

Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

In addition, recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumour cores.

Eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.

Recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumour cores.

Eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.

It was first approved for use in the treatment of metastatic breast cancer in the United States in November 2010, and is currently approved for use in the treatment of breast cancer in approximately 60 countries including Japan and countries in Europe, the Americas and Asia.

In addition, eribulin was first approved for use in the treatment of soft tissue sarcoma in the United States in January 2016, and is approved in countries including Japan and in Europe.

Source: ACN Newswire and JSMO

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