Morphotek Inc. farletuzumab Phase 3 Study Fails to Meet Primary Endpoint
Published: Jan 11, 2013
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.
Farletuzumab is a humanized, IgG1 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.
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.
SOURCE Morphotek Inc.