Exton, PA April 18, 2016 -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that results from the Phase 3 MORAb-003-004 trial were recently published in the Journal of Clinical Oncology. The MORAb-003-004 clinical trial (also known as FAR-131) was a randomized, double-blind, placebo-controlled, Phase 3, global study of the safety and efficacy of weekly farletuzumab (MORAb-003) in combination with a platinum standard chemotherapy regimen (carboplatin plus taxane) in platinum-sensitive ovarian cancer patients in first relapse. Farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha (FRA), which is highly expressed in epithelial cancers, such as ovarian, but mostly absent from normal tissue.
All subjects received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomized test product 1:1:1 farletuzumab 1.25 mg/kg, farletuzumab 2.5 mg/kg, or placebo), and single-agent test product was continued weekly until disease progression. Neither farletuzumab dose met the study’s primary progression-free survival (PFS) endpoint when compared to placebo, with PFS of 9.0, 9.5 (hazard ratio [HR] = 0.99) and 9.7 months (HR = 0.86) for the placebo, farletuzumab 1.25 mg/kg, and farletuzumab 2.5 mg/kg arms, respectively. There was no difference in overall survival. Prespecified subgroup analyses demonstrated that subjects with a low CA125 level (less than three times the upper limit of normal) correlated with longer PFS (HR=0.49) and OS (HR=0.44) for farletuzumab 2.5 mg/kg versus placebo. Subjects with higher farletuzumab exposure also showed superior PFS and OS compared to placebo. CA125 is a tumor-produced protein elevated in the blood of some ovarian cancer patients that has been previously reported to reduce natural killer (NK) cell function; therefore, higher CA125 levels may interfere with the immune response associated with farletuzumab’s potential activity.
The most common adverse events were those known to be associated with chemotherapy, including: alopecia; nausea; neutropenia; fatigue; thrombocytopenia; and neuropathy.
Based on the encouraging results from the prespecified subgroup analyses, Morphotek has initiated a Phase 2 trial, MORAb-003-011, to further investigate the potential clinical benefit observed in the MORAb-003-004 patients with a low CA125 level. This global study will assess the safety and efficacy of farletuzumab, using a modified dosing schedule guided by exposure-response analysis from the Phase 3 study, in combination with a platinum doublet in first-relapsed, platinum-sensitive ovarian cancer patients with low CA125 blood levels.
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.