Clinical Study (MORAb-009-201) of the Safety and Efficacy of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects with Unresectable Malignant Pleural Mesothelioma (MPM)
EXTON, Pa., Nov. 18, 2015 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has enrolled the first patient in the randomized, double-blind ARTEMIS—Amatuximab Research in Treatment-naïve Epithelial Mesothelioma: Impact on Survival—trial. The study will evaluate the efficacy and safety of amatuximab, a monoclonal antibody that targets mesothelin, when combined with the standard chemotherapy regimen pemetrexed plus cisplatin.
The MORAb-009-201 study design is based on the exposure response results of the completed 89-patient MORAb-009-003 Phase 2 study. It is a randomized, double-blind, placebo-controlled trial to determine if amatuximab improves the overall survival of MPM patients. All patients will receive the standard-of-care chemotherapy regimen for four to six cycles combined with either amatuximab or placebo, followed by maintenance therapy with either amatuximab or placebo. Secondary objectives include evaluating progression-free survival, objective response rate, duration of response, disease control and performance status maintenance, disease control rate, health-related quality of life, and safety. Morphotek expects to enroll 560 patients in this study, which will be conducted in sites across Australia, Europe and the United States.
"We are excited to initiate this global study of amatuximab. The exposure-response modeling in the MORAb-009-003 trial indicates a potential role for amatuximab in this disease where the current standard of care provides a median overall survival of approximately 13.3 months," stated Nicholas Nicolaides, Ph.D., President and CEO of Morphotek. "Mesothelioma is a rare and aggressive cancer with poor prognosis; therefore, further investigation of amatuximab in this area of unmet need is warranted."
Amatuximab is a monoclonal antibody (mAb) that triggers antibody-dependent cellular cytotoxicity against tumor cells expressing mesothelin and blocks the ability of mesothelin to bind to its cognate receptor on adjacent cells. Mesothelin is a cell-surface glycoprotein believed to be involved in tumor metastasis; it is expressed in mesothelioma and other solid tumors, such as epithelial ovarian cancer, lung adenocarcinoma and pancreatic ductal adenocarcinoma.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT02357147.
About MORAb-009-003 Phase 2 study
Previously, Morphotek conducted a global, single-arm, open-label, Phase 2 study testing whether amatuximab plus standard of care could improve progression-free survival in patients with newly diagnosed, unresectable, epithelioid or biphasic, malignant pleural mesothelioma. Secondary endpoints included overall response, overall survival and safety. Results of this MORAb-009-003 study showed that amatuximab failed to statistically improve progression-free survival in the intent to treat population compared to historic controls; however, the 14.8-month median overall survival compared favorably to the historical control of 13.3 months. These results, along with dose modeling, suggested an opportunity to improve median overall survival in the majority of patients using a modified dosing schema than what was used in the MORAb-009-003 study. Based on these findings, further study of amatuximab using a more frequent dosing schedule is being pursued.
About Morphotek
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.
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