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Morphotek Announces Top-Line Results of a Phase III Study of Farletuzumab in Patients With Relapsed Platinum-Sensitive Epithelial Ovarian Cancer
By: PR Newswire
Jan. 10, 2013 06:30 PM
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
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 Ovarian Cancer
About Eisai Inc.
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.
SOURCE Morphotek Inc.
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