Watch Live

Tweet TWEET

Morphotek Announces Top-Line Results of a Phase III Study of Farletuzumab in Patients With Relapsed Platinum-Sensitive

 Morphotek Announces Top-Line Results of a Phase III Study of Farletuzumab in
     Patients With Relapsed Platinum-Sensitive Epithelial Ovarian Cancer

PR Newswire

EXTON, Pa., Jan. 10, 2013

EXTON, Pa., Jan. 10, 2013 /PRNewswire/ --Morphotek^® Inc., a wholly-owned
subsidiary of Eisai Inc., announced today top-line results from a Phase III
study of its investigational agent farletuzumab (MORAb-003) in combination
with carboplatin and a taxane in patients with platinum-sensitive epithelial
ovarian cancer in first relapse.

The study found that farletuzumab in combination with carboplatin and a taxane
did not meet the study's primary endpoint of progression-free survival (PFS).
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
relevant health authorities.

In the double-blind, placebo-controlled study, 1,100 patients were enrolled to
receive standard-of-care (carboplatin and a taxane [paclitaxel or docetaxel])
chemotherapy and were randomized to three parallel groups to receive one of
two different dose levels of farletuzumab or placebo.

"While we are disappointed with these results, we know that ovarian cancer is
a difficult disease to treat successfully," says Dr. Nicholas Nicolaides,
President and CEO of Morphotek. "Morphotek remains committed to research to
understand the potential role of farletuzumab in ovarian and other types of
cancer."

FAR 131 Study Design
The Phase III trial, also known as FAR 131, was a randomized, multicenter,
double-blind, placebo-controlled study assessing the efficacy and safety of a
weekly dose of farletuzumab in combination with standard-of-care (SOC)
(carboplatin and a taxane [paclitaxel or docetaxel]) chemotherapy as assessed
by the Response Evaluation Criteria in Solid Tumors (RECIST) in patients with
platinum-sensitive ovarian cancer in first relapse. In the study, 1,100
patients at 274 medical centers participated globally.

Patients received SOC and were randomized to three parallel groups to receive
either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo.
Patients received SOC every three weeks, and weekly farletuzumab or placebo
for approximately six cycles. After approximately six cycles, patients
received maintenance of placebo, 1.25 mg/kg or 2.5 mg/kg of farletuzumab until
progression.

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 relapsed
between six and 24 months from the time of completion of first-line
platinum/taxane therapy. They also had to be eligible for carboplatin/taxane
treatment.

About Farletuzumab
Farletuzumab is a humanized, IgG[1] monoclonal antibody (mAb) 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 laboratory-generated
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.

About Ovarian Cancer
In the US, an estimated 22,280 new cases of ovarian cancer will have been
diagnosed in 2012, causing 15,500 deaths. ^ Most patients with ovarian cancer
(approximately 90 percent) have epithelial (carcinomas) and are often
diagnosed with advanced-stage disease. Although clinical complete remissions
are obtained in the majority of patients through a combination of
cytoreductive surgery and chemotherapy, relapse is common.

About Morphotek
Morphotek specializes in the development of protein and antibody products
through the use of a novel and proprietary gene evolution technology. In the
spring of 2007, Morphotek was acquired by Eisai Inc., a global health care
pharmaceutical company. Morphotek's proprietary technologies and promising
antibodies, combined with Eisai's existing research programs and
infrastructure, enables the companies to work toward addressing unmet medical
needs of patients, especially those with cancer and inflammatory diseases, all
around the world. For more information, please visit www.morphotek.com.

About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in
the United States in 1997. Since that time, Eisai Inc. has rapidly grown to
become a fully integrated pharmaceutical business. Eisai's key areas of
commercial focus are neurology and oncology. The company serves as the U.S.
pharmaceutical operation of Eisai Co., Ltd., a research-based human health
care (hhc) company that discovers, develops and markets products throughout
the world.

Eisai has a global product creation organization that includes U.S.-based R&D
facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as
well as manufacturing facilities in Maryland and North Carolina. The company's
areas of R&D focus include neuroscience; oncology; vascular, inflammatory and
immunological reaction; and antibody-based programs. For more information
about Eisai, please visit www.eisai.com/US.

Media Inquiries
                      Investor Inquiries
Laurie Ostroff-Landau
                      Alex Scott
Eisai Inc.
                      Eisai Inc.
201-746-2510
                      201-746-2177

                      


SOURCE Morphotek Inc.

Website: http://www.morphotek.com
 
Press spacebar to pause and continue. Press esc to stop.