ArQule Inc., a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics, and Daiichi Sankyo Co., Ltd. have completed the patient recruitment in randomized, double-blind, controlled phase III MARQUEE pivotal trial of their investigational selective c-MET inhibitor, tivantinib, in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).

The MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial began enrollment in January 2011 and is being conducted under a Special Protocol Assessment (SPA), which was established following agreement with the US Food and Drug Administration (FDA). Tivantinib is currently in phase III development and has not yet been approved for any indication.

“At the time of diagnosis with lung cancer, more than half of all patients have progressed to advanced stages of the disease, with a poor prognosis for long-term survival. There is a high unmet need for additional effective treatment options for patients and their families,” said Glenn Gormley, MD, PhD, Global Head, Research & Development and senior executive officer, Daiichi Sankyo and president, Daiichi Sankyo Pharma Development.

Lung cancer is one of the most commonly diagnosed cancers around the globe, with an estimated 1.6 million new cases diagnosed worldwide each year. NSCLC is the most common form of lung cancer, accounting for approximately 85 per cent of all cases. The majority of all lung cancers are non-squamous.

“We would like to thank the patients, investigators and clinical sites who are participating in the MARQUEE trial,” said Brian Schwartz, chief medical officer of ArQule. “Their commitment, diligence and care have been essential in the timely achievement of this important milestone in the development of tivantinib.”

Approximately 1,000 patients have been recruited in MARQUEE from more than 200 clinical sites worldwide. The primary endpoint in the trial is overall survival in the overall intent-to-treat population. Professor Giorgio Scagliotti, MD, PhD, Head of the Department of Clinical and Biological Sciences at S. Luigi Hospital, Orbassano (Torino), Italy is the principal European investigator for MARQUEE, and the principal U.S. investigator is Alan Sandler, MD, Professor of Medicine in the Division of Hematology and Medical Oncology, Department of Medicine, at Oregon Health and Science University in Portland.

In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement to co-develop tivantinib (ARQ 197) in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.