Phase III data for Halaven (eribulin) in soft tissue sarcoma used for submission to EU for extended indication- Eisai

Phase III data showed that Halaven (eribulin), from Eisai, offers a significant overall survival benefit in people with advanced leiomyosarcoma (LMS) or adipocytic sarcoma (liposarcoma), compared to dacarbazine (13.5 vs 11.5 months respectively, HR=0.768, 96% CI 0.618-0.954; P=0.017). Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. These data were presented at the German Association of Hematology and Oncology (DGHO) 2015 meeting.

A further study presented at the DGHO 2015 showed that women with metastatic breast cancer treated with eribulin in combination with capecitabine (n=42) had an overall response rate of 42.9% (4.8% complete response and 38.1% partial response), and median progression free survival of 7.1 months (95% CI:4.4–9.8). This study confirms the safety and efficacy of the dose-combination eribulin 1.23 mg/m² and capecitabine 1000 mg/m² twice daily. The safety and tolerability profile of the combination was consistent with previous data. These data were supported at DGHO by a case study, which showed that a patient treated with 34 cycles of palliative chemotherapy with eribulin tolerated treatment well and went into continuous partial remission.

Based on these data, the company has submitted an application to extend the indication of Halaven (eribulin) in the European Union for the treatment of patients with inoperable soft tissue sarcoma who have received prior chemotherapy for locally advanced or metastatic disease.

Comment: Eribulin is currently indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.