Lancet Publishes First Trial To Show Overall Survival Benefit Of Halaven® (eribulin) in People With Soft Tissue Sarcoma Sub-Types - Seite 2

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]

Eisai is dedicated to discovering, developing and producing
innovative oncology therapies that can make a difference and impact
the lives of patients and their families. This passion for people is
part of Eisai's human health care (hhc) mission, which strives for
better understanding of the needs of patients and their families to
increase the benefits health care provides.

Notes to Editors

Halaven® (eribulin)

Eribulin is the first in the halichondrin class of microtubule
dynamics inhibitors with a novel mechanism of action. Structurally
eribulin is a simplified and synthetically produced version of
halichondrin B, a natural product isolated from the marine sponge
Halichondria okadai. Eribulin is believed to work by inhibiting the
growth phase of microtubule dynamics which prevents cell division.

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.[10]

About Soft Tissue Sarcomas

Soft tissue sarcoma is a collective term for a diverse group of
malignant tumours.

Unlike other cancers such as non-small cell lung cancer (NSCLC),
soft tissue sarcomas are mostly diagnosed with localised disease, and
many are amenable to complete surgical removal, yet relapse rates can
be as high as 50 percent.[11]Outcomes for patients with advanced
disease are poor, with median survival around one year or less. Due
to the rarity of these tumours, evidence for prognostic factors is
weak and not well understood.[5]

Global Phase III Clinical Study 309[1]

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.[1]

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