TOKYO and WOBURN, Massachusetts, January 12, 2011 /PRNewswire/ -- Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. today announced that the first patient has been enrolled in the phase III trial of ARQ 197, an investigational selective inhibitor of the c-Met receptor tyrosine kinase, in combination with erlotinib, for patients diagnosed with non-squamous, non-small cell lung cancer (NSCLC), who have received one or two prior systemic anti-cancer therapies.
The phase III trial is a randomised, double-blinded, controlled study of previously treated patients with locally advanced or metastatic, non-squamous NSCLC who will receive ARQ 197 plus erlotinib or placebo plus erlotinib.
The primary objective is to evaluate the overall survival (OS) in the intent-to-treat (ITT) population. Secondary endpoints include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, progression-free survival (PFS) in the ITT population, and further assessment of the safety of ARQ 197 in combination with erlotinib.
According to the International Agency for Research on Cancer, more than 1.6 million new cases of lung cancer were diagnosed in 2008 globally,[1] and NSCLC accounted for 80 percent of those cases.[2] According to the American Cancer Society more than 220,000 cases of lung cancer will have been diagnosed in 2010 in the U.S.[3] Of patients diagnosed with lung cancer in Europe, almost 90 percent die of the disease.[4]
"With lung cancer accounting for more deaths than colon, breast and prostate cancers combined,[5] we are very pleased to begin this phase III trial to advance the knowledge about the role ARQ 197 might have in the treatment of patients with non-small cell lung cancer in combination with erlotinib," said Dr. Kazunori Hirokawa, global head of R&D Unit, Daiichi Sankyo. "It is our hope and expectation that this late-stage study will confirm the results we observed in patients with non-squamous cell histology in phase II, which showed promise toward extending overall survival and progression-free survival in this group when ARQ 197 was combined with erlotinib."
"The start of this phase III trial marks a key milestone in the development of ARQ 197 and our partnership with Daiichi Sankyo," said Paolo Pucci, chief executive officer of ArQule. "Lung cancer is a devastating disease, and our hope is that ARQ 197 will prove to be an effective treatment option that will help patients diagnosed with this disease."
In October 2010, agreement was reached with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase III trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo. The phase III study of ARQ 197 plus erlotinib will enroll 988 patients in 150 sites in the U.S., Canada, Eastern and Western Europe, Australia and Latin America. Additional details are available on http://www.clinicaltrials.gov.
About ARQ 197 and c-Met
ARQ 197 is an orally available, selective inhibitor of c-Met, a receptor tyrosine kinase that is currently in phase II and phase III clinical trials and is not yet approved for use. In healthy adult cells, c-Met is present in normal levels to support natural cellular function, but in cancer cells, c-Met is inappropriately and continuously activated for unknown reasons. When abnormally activated, c-Met plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
Pre-clinical data have demonstrated that ARQ 197 inhibits c-Met activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with ARQ 197 has been well-tolerated and has resulted in tumor responses and prolonged stable disease across a broad range of tumors.
In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialisation agreement to co-develop ARQ 197 in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co., Ltd. has exclusive rights for development and commercialisation.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimise growth opportunities across the value chain. For more information, please visit http://www.daiichisankyo.com.
The company's world headquarters are in Tokyo. Its European base is located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12 European countries in addition to a global manufacturing site located in Pfaffenhofen, Germany.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule's lead product, in phase II and phase III clinical development, is ARQ 197, an inhibitor of the c-Met receptor tyrosine kinase. The Company has also initiated phase I clinical testing with ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and with ARQ 736, designed to inhibit the RAF kinases. ArQule's current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP(TM)), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.
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