Eisai’s Phase III trial of sarcoma drug Halaven meets primary endpoint

In the trial, eribulin showed a statistically significant extension in overall survival (OS) over the comparator treatment dacarbazine, the primary endpoint of the study.

The company said that no other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a Phase III trial.

Eisai EMEA CEO and Global Oncology Business Unit president Gary Hendler said: "Overall Survival is recognized as the most definitive cancer outcome and is universally accepted as the direct measure of benefit in cancer treatments and this study demonstrates that eribulin has the potential to become an important additional treatment option for patients with this aggressive and rare cancer that requires chemotherapy."

The randomized, open-label multicenter Phase III trial compared the efficacy and safety of eribulin in 452 patients aged 18 years and above.

During the trial, treatment was administered on days one and eight of a 21-day cycle versus dacarbazine to patients with one of two subtypes: adipocytic or leiomyosarcoma locally advanced or relapsed and metastatic soft tissue sarcoma.

The company plans to submit regulatory applications during the first half of the fiscal year of 2015 to the regulatory authorities in multiple countries including the US, Europe and Japan seeking an expansion of the indication for eribulin including soft tissue sarcoma.

Currently, eribulin is indicated to treat women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.