Eisai Announces Results of Phase III Study of Anticancer Agent F

Eisai Announces Results of Phase III Study of Anticancer Agent Farletuzumab in
Patients with Relapsed Platinum-Sensitive Ovarian Cancer 
Tokyo, Jan 11, 2013 - (JCN Newswire) - Eisai Co., Ltd. announced today the
preliminary results of its global Phase III study (Study FAR 131,
MORAb-003-004) of farletuzumab (MORAb-003), an investigational compound under
development at its U.S. subsidiary, Morphotek, Inc., in patients with
platinum-sensitive epithelial ovarian cancer in first relapse. 
The study was a multicenter, randomized, double-blind, placebo-controlled,
parallel-group comparative study of 1,100 patients with platinum-sensitive
epithelial ovarian cancer in first relapse. The patients received
standard-of-care therapy (carboplatin and a taxane) in combination with doses
of either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo. 
Preliminary results showed that the trial did not meet the pre-specified
statistical criteria for significant progression-free survival (PFS), the
study's primary endpoint. The post hoc exploratory analysis showed,
however, a trend toward improved PFS in some patient subsets and further
analysis is ongoing. The preliminary safety analysis indicated that the most
commonly reported adverse events were those known to be associated with the
study chemotherapy agents. Additionally, some immune-mediated events were
observed with farletuzumab. After further analysis of these clinical results,
the company will determine a new development strategy based on discussion with
external experts and the relevant health authorities. 
Eisai remains committed to understanding the potential clinical benefits of
farletuzumab in order to further contribute to patients with cancer, including
patients with recurrent ovarian cancer, and their families. 
About farletuzumab 
Farletuzumab is a humanized, IgG1 monoclonal antibody that binds to the folate
receptor-alpha (FRA), a folate-binding protein that is expressed on ovarian and
several other epithelial cancer cells. Monoclonal antibodies are a type of
immunotherapy used to treat cancer that are manmade versions of immune system
proteins and can be designed to attack a specific part of a cancer cell.
Immunotherapy drugs offer a method of treatment separate from chemotherapy. 
Study FAR 131 Design Summary 
This Phase III trial was a multicenter, randomized, double-blind,
placebo-controlled, parallel-group comparative study of 1,100 patients with
platinum-sensitive epithelial ovarian cancer in first relapse enrolled in 274
medical centers. The study assessed the efficacy and safety of farletuzumab in
combination with standard-of-care carboplatin and taxane (either a paclitaxel
or docetaxel) chemotherapy. The primary endpoint was progression-free survival
(PFS) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Patients were randomized into three parallel groups to receive either a 1.25
mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab or placebo, with all patients
receiving standard-of-care therapy every three weeks and farletuzumab or
placebo weekly for six cycles. After these six cycles, patients continued to
receive their maintenance of placebo or farletuzumab until disease progression
was observed. 
Eligible patients must have been treated initially with surgery, had a
response to first-line platinum- and taxane-based therapy, and have relapsed as
defined by the presence of measurable disease. Patients must have also relapsed
between 6 and 24 months from the time of completion of their first-line
platinum and taxane therapy and been eligible for carboplatin and taxane
treatment. 
About Ovarian Cancer 
Globally, an estimated 225,000 patients are diagnosed with ovarian cancer each
year, with an estimated 140,000 deaths due to this disease annually.
Approximately 90% of ovarian cancer tumors are epithelial (carcinomas) and
often not diagnosed until the advanced stages of the disease. Although clinical
complete remissions are obtained in the majority of patients through a
combination of cytoreductive surgery and chemotherapy, relapse remains common. 
Eisai's Commitment to Oncology 
Eisai's commitment to meaningful progress in oncology research, built on
scientific expertise, is supported by a global capability to conduct discovery
and preclinical research, and develop small molecules, biologics,
chemotherapies and supportive care agents for cancer across multiple
indications. Along with its continued endeavors in obtaining further indication
expansion for Halaven(R), Eisai plans to enhance its portfolio of products in
the field of oncology with other agents such as its monoclonal antibody
farletuzumab and lenvatinib, a VEGF (vascular endothelial growth factor)
receptor tyrosine kinase inhibitor and multikinase inhibitor. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Contact: 
Eisai Co., Ltd.,
Public Relations Department.
+81-3-3817-5120 
Copyright 2013 JCN Newswire. All rights reserved. www.japancorp.net 
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