Study 309 was a randomized, open-label, multicenter trial of eribulin mesylate in patients with locally advanced or recurrent and/or metastatic adipocytic sarcoma or leiomyosarcoma who had disease progression following two standard therapies which must have included an anthracycline and at least one additional regimen after anthracycline failure. Eribulin was given on days one and eight of a 21-day cycle vs. dacarbazine given on day one, every 21 days to 452 patients. The primary endpoint of the study was to compare overall survival (OS) between both treatment arms. The primary endpoint in this trial was met, demonstrating a statistically significant improvement in OS in patients treated with eribulin vs. dacarbazine.
Halaven (eribulin mesylate) is already indicated for the treatment of metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Previously the Food and Drug Administration (FDA) granted eribulin Orphan Drug designation for the treatment of soft tissue sarcoma. Eisai plans to submit applications this year to the FDA seeking an expansion of the indication for eribulin to include soft tissue sarcoma.
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