Eisai Co., Ltd. announced today that the results of an additional analysis of a Phase III clinical study (Study 309) of its in-house discovered and developed anticancer agent Halaven® (eribulin mesylate, “eribulin”) in patients with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) have been presented 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).
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].