Full results of study 309 published for the first time in The Lancet 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.2 In addition to the full results, The Lancet has also published an editorial in which the results of the study are discussed.3
"This is the first data of a single agent therapy to show such a benefit. The fact that these results have been published in such a prestigious clinical journal, shows their importance in this area of unmet need," commented Patrick Schöffski, Head of the Department of General Medical Oncology, University Hospitals Leuven, Belgium. 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.1 Leiomyosarcomas and liposarcomas make up around 30% of all cases of soft tissue sarcomas2 and develop from cells in the tissues that surround the body such as fat, muscle, nerves, fibrous tissues and blood.4 Leiomyosarcomas form from cells called smooth muscle and can start anywhere in the body,4 while liposarcomas (adipocytic sarcomas) originate in fat cells and can also occur anywhere in the body.4
"We are proud to see these data published in The Lancet and will continue to develop compounds that make a positive difference to the lives of people with cancer and their loved ones. We are delighted that eribulin has been licensed in the US in this important soft tissue sarcoma subtype", comments Gary Hendler, President, Eisai Global Oncology Business Unit and President & CEO Eisai EMEA.
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 Food and Drug Administration (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.
Though soft tissue sarcomas are relatively rare, they carry a poor prognosis, with many people unresponsive to treatment.5 In Europe, approximately 29,000 people are diagnosed with soft tissue sarcomas each year.6 Approximately 11,930 cases of soft tissue sarcomas will have been diagnosed in the United States this year.7 In Japan, approximately 2,000 cases of soft tissue sarcomas are diagnosed each year.8, 9