Lancet Publishes First Trial To Show Overall Survival Benefit Of Halaven® (eribulin) in People With Soft Tissue Sarcoma Sub-Types

Hatfield, England (ots/PRNewswire) -

An application to extend the indication of eribulin for the
treatment of patients with unresectable locally advanced soft tissue
sarcoma subtypes has been submitted in the EU

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 sarcomas[2] 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