• Feb 26, 2015
• Breast Cancer Arabia Team
• 0

A statistically significant improvement in overall survival has been noted in a phase 3 trial in patients with advanced soft tissue sarcoma after treatment with eribulin (Halaven, Eisai) when compared with dacarbazine.
 

The manufacturer says that it will submit an application for approval of the drug in sarcoma based on these data, which are currently unspecified but will be presented at a medical meeting later in the year.
 

Eribulin is marketed for use in breast cancer; it was approved in the United States in 2010 on the basis of a phase 3 trial in heavily pretreated metastatic breast cancer patients, where it showed improved survival compared with physician’s choice of treatment.
 

The new data in sarcoma come from Study 309, a randomized open-label multicenter trial conducted in 452 patients with locally advanced or recurrent and/or metastatic adipocytic sarcoma or leiomyosarcoma. These patients had disease progression following two standard therapies, which must have included an anthracycline and at least one additional regimen after anthracycline failure.
 

The trial compared treatment with eribulin mesylate (1.4 mg/m² administered intravenously on days 1 and 8 of a 21-day cycle) versus dacarbazine (intravenously on day 1 of every 21 days, for a dose range of 850 mg/m² to 1200 mg/m²).
 

No results have yet been reported, other than the top-line finding that the primary end point of overall survival was significantly longer with eribulin.
 

In this study, the most common adverse events observed in the eribulin group were neutropenia, fatigue, nausea, alopecia, and constipation, according to the company.
 

“The study results show the potential role of eribulin for the treatment of patients with soft tissue sarcoma, where a need exists for additional treatment options,” said Kenichi Nomoto, PhD, president of the oncology product creation unit at Eisai.
 

The company will seek approval for sarcoma in the United States, Europe, and in Japan.
 

In the United States, the drug has been granted orphan drug designation for the indication of soft tissue sarcoma by the US Food and Drug Administration.
 

Approximately 12,000 cases of soft tissue sarcoma will be diagnosed in the United States in 2015, and 4700 Americans are expected to die of the disease. While many patients with soft tissue sarcoma are diagnosed early in their disease and are curable with surgery, outcomes for patients with advanced or metastatic disease are poor, and median survival is around 1 year or less, the company noted.
 
 
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