Date: 2016-06-21
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The Lancet
Company: Eisai (Japan)
Product: Halaven® (eribulin)
Action
mechanism: mitotic inhibitor/tubulin binder. Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane. Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Disease: unresectable locally advanced liposarcoma and leiomyosarcoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On February 11, 2016, Eisai annouonced that full results of study 309 have been published in The Lancet. These results show Halaven ® (eribulin) improved median overall survival compared to dacarbazine for people with unresectable locally advanced liposarcomas and leiomyosarcomas,[1] two of the most common forms of soft-tissue sarcoma. In addition to the full results, The Lancet has also published an editorial in which the results of the study are discussed.
Study 309 included data from 452 people (aged 18 and over) with leiomyosarcomas or liposarcomas to compare the efficacy and safety of eribulin to dacarbazine. The primary endpoint of the study was to compare overall survival between patients treated with eribulin mesilate (1.4 mg/m² intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/m², 1000 mg/m², or 1200 mg/m² [dose dependent on centre and clinician] intravenously on day 1). The additional endpoints included progression free survival and quality of life.
Patients were aged ?18 years with advanced high/intermediate grade leiomyosarcoma or dedifferentiated, myxoid, round cell or pleomorphic variants of adipocytic sarcoma (ADI) incurable by surgery and/or radiotherapy were enrolled. Patients had ECOG status ?2 and had received ?2 standard systemic treatment regimens including an anthracycline. Patients were randomized 1:1 to eribulin mesilate (1.4 mg/m2, IV on D1 and D8) or dacarbazine (850-1200 mg/m2, IV on D1) every 21 days until disease progression.
Overall, 452 patients (67% female; 79% In July a Type II variation application to extend the indication of eribulin was submitted in the European Union for the treatment of patients with unresectable soft tissue sarcoma who have received prior chemotherapy for locally advanced disease. In the US, the FDA approval was granted on January 28 2016 for eribulin in the treatment of patients with unresectable liposarcoma who have received a prior anthracycline containing regimen. A similar application was submitted in Japan.
