Farletuzumab Data Presented on Phase II Clinical Trial in First-Relapsed Ovarian Cancer Subjects
Berlin (ots/PRNewswire)
Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA). (1A)
These data were presented today at the joint 15th Congress of the European Cancer Organisation (ECCO) and the 34th Congress of the European Society for Medical Oncology (ESMO) by Deborah Armstrong, M.D., Associate Professor of Oncology, Johns Hopkins Kimmel Cancer Center and a farletuzumab study investigator.
Preliminary data from the study indicate that farletuzumab, in combination with standard platinum and taxane chemotherapy, shrank or eliminated the tumor in 69.8% of subjects; in addition, 23% of the subjects had their tumor stabilized.(2A) The results of the study also showed that in more than 20% of subjects the second progression-free interval was as long as or longer than the first.(2B)
The most common drug-related adverse events observed in this study were fever and chills related to infusion, which tended to be mild. No significant increase in severe adverse events above those expected with chemotherapy alone was reported during combination therapy.(2C)
"The rate of relapse of ovarian cancer is high, and over time standard chemotherapeutic agents become ineffective in treating relapsed ovarian cancer patients," said Martin D. Phillips, M.D., Chief Medical Officer at Morphotek. "We are excited about these new data and look forward to seeing results from our ongoing global Phase III trial testing farletuzumab in combination with platinum and taxane in platinum-sensitive ovarian cancer."
"The results of this Phase II study presented today support our commitment to continue to develop farletuzumab for ovarian cancer," said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. "Our research with farletuzumab is consistent with our human health care (hhc) mission - addressing unmet medical needs by developing new treatment options that will improve the lives of patients."
Study Details
The primary objectives of the open-label Phase II study included: to measure overall response rate (ORR), to compare the length of a subject's second remission with her first remission and to measure change in CA-125 level.(3A) Approximately 20 centers in the United States, Germany and the Netherlands participated in the study.
Thirty-nine (88.6%) of the 44 eligible subjects receiving farletuzumab in combination with platinum and taxane had their CA-125 blood levels normalized,(2D) and three additional subjects had a 50% decrease.(2E) (According to the National Cancer Institute, CA-125 is a tumor marker frequently elevated in ovarian cancer. It is typically used to evaluate tumor response, as CA-125 levels generally correlate with tumor activity.)(4A) In nine (20.5%) of these 44 subjects, the second remission was equal to or longer than the first remission.(2F)
About Ovarian Cancer
Ovarian cancer forms in the tissue of the ovary. Most ovarian cancers are epithelial carcinomas (cancer that begins in the cells on the surface of the ovary).(5A)
Ovarian cancer, which ranks fifth as the cause of cancer deaths in women,(6A) usually grows asymptomatically before it is discovered.(7A) In Europe, it is estimated that there are 61,000 cases of ovarian cancer each year.(8A) The National Cancer Institute estimates that there were 21,550 new cases of ovarian cancer in the United States in 2009 and 14,600 deaths from the disease.(5B)
About Farletuzumab
Farletuzumab (MORAb-003) is a humanized monoclonal antibody in development for the potential treatment of advanced ovarian cancer. In vitro, farletuzumab appears to have antiproliferative and cytotoxic activities in tumor cells that over express FRA.
A randomized global Phase III study to test farletuzumab in combination with platinum and taxane (P/T) in platinum-sensitive ovarian cancer subjects is currently underway.(9A) For more information about the Phase III trial, please visit www.far-trials.com or www.clinicaltrials.gov.
About Morphotek
Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a 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 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.
Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
Eisai in Europe
Eisai Europe Limited (EEL) is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operations across Europe, where Eisai has sales and marketing operations in over 20 markets, including: the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, and Slovakia. In addition, other Eisai operating companies in Europe carry out basic discovery research; distribution & logistics; clinical research; and manufacturing.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
Eisai concentrates its R&D activities in three key areas:
- Integrative Neuroscience, including Alzheimer's disease,
neuropathic pain and epilepsy.
- Integrative Oncology, including anticancer therapies, tumor
regression, tumor suppression and antibodies; supportive cancer
therapies include nausea and vomiting.
- Vascular/Immunological Reaction including acute coronary
syndrome, atherothrombotic disease and sepsis.(1) Morphotek, Inc. and Eisai Corporation of North America ESMO abstract. "Efficacy and safety of farletuzumab, a humanized monoclonal antibody to folate receptor alpha, in platinum-sensitive relapsed ovarian cancer subjects: preliminary data from a phase-2 study."
A. Pg. 1, col. 1, par. 1
B. Pg. 1, col. 1., par 3(2) Deborah Armstrong, MD. Johns Hopkins University/Kimmel Cancer Center. "Exploratory Phase 2 Efficacy Study of MORAb-003, a Monoclonal Antibody against Folate Receptor Alpha, in Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse." Joint ECCO 15 - 34th ESMO Multidisciplinary Congress Slide Presentation.
A. Pg. 20, col. 1, par. 1
B. Pg. 23, col. 1, par. 3
C. Pg. 22, col. 1, par. 2 and 3
D. Pg. 15, col. 1, par. 1 and 2
E. Pg. 15, col. 2, par. 2 (Rustin response)
F. Pg. 15, col. 1, par. 3(3) Morphotek, Inc. Clinical Trial Protocol: MORAb-003-002, Morphotek, Inc., "A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse." Revised April 9, 2007.
A. Pg. 8, col. 1, par. 6
(4) National Cancer Institute. CA-125. Available at http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=46490. Accessed September 10, 2009.
A. Pg. 1, col. 1., par. 1
(5) National Cancer Institute. Ovarian Cancer. Available at: http://www.cancer.gov/cancer_information/cancer_type/ovarian/. Accessed September 10, 2009.
A. Pg. 1, col. 1, par. 1
B. Pg. 1, col. 1, par. 2(6) American Cancer Society. Cancer Statistics 2009 Slide. Slide 2. Available at: http://www.cancer.org/docroot/PRO/content/PRO_1_1_Ca ncer_Statistics_2009_Pres entation.asp. Accessed September 10, 2009.
A. Pg. 2, col. 2, par. 1
(7) National Cancer Institute. Ovarian Cancer Symptoms. Available at: http://www.cancer.gov/cancertopics/wyntk/ovary/page5. Accessed September 11, 2009.
A. Pg. 1, col. 1., par 1 and 4
(8) Cancer Intelligence, sponsored by Professor Gordon McVie, former Chief Executive of The Cancer Research Campaign and joint Chief Executive of the new charity Cancer Research UK and current consultant at the European Institute of Oncology. Ovarian Cancer. Available at: http://www.ecancermedia.com/Ovarian_Cancer_Factsheet.aspx. Accessed September 11, 2009.
A. Pg. 4, col. 1, par. 10
(9) Morphotek, Inc. Clinical Trial Protocol: MORAb-003-004, Morphotek, Inc., "A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse." Revised February 2, 2009.
A. Pg. 2, col. 1., par 2
Nonpro-EU2004
Contact:
Judee Shuler, Eisai Inc., +1-201-746-2241, judee_shuler@eisai.com; or
Robert Laverty, Eisai Corporation of North America, +1-201-746-2265,
robert_laverty@eisai.com