ArQule’s Lead Cancer Drug Fails Another Clinical Trial

More bad news for ArQule’s (NASDAQ: [[ticker:ARQL]]) lead drug candidate, tivantinib. Just months after the drug failed a Phase 3 trial  in non-small cell lung cancer, ArQule said today that tivantinib also failed in a Phase 2 trial against colorectal cancer. The Woburn, MA-based company is developing the drug in partnership with Daiichi Sankyo of Japan.

ArQule’s stock price dropped as much as 23 percent in pre-market trading on the news, and by 10 a.m. was down 13.36 percent to $2.53. The stock plunged by more than half, to $2.18, when the company announced the lung cancer trial results in October.

The company said that in the 122-patient trial, tivantinib did not meet its main goal of improving progression-free survival, the length of time that a cancer does not worsen. The drug also failed to provide statistically significant improvements in objective response rate, a measurement of tumor size.

ArQule and Daiichi said they will hold further discussions with key clinicians in the field of colorectal cancer to decide “how best to proceed with further clinical development of tivantinib in this tumor type.”

Tivantinib, taken orally, is designed to block c-MET, a protein that plays a role in the growth of tumors. Cancer experts have been closely watching this drug because c-MET is implicated in a range of cancers. ArQule has been co-developing the drug with Daiichi Sankyo since 2008, and still has plans for a Phase 3 trial of the drug for hepatocellular carcinoma, a form of liver cancer.

Author: Catherine Arnst

Catherine Arnst is an award- winning writer and editor specializing in science and medicine. Catherine was Senior Writer for medicine at BusinessWeek for 13 years, where she wrote numerous cover stories and wrote extensively for the magazine’s website, including contributing to two blogs. She followed a broad range of issues affecting medicine and health and held primary responsibility for covering the battle in Washington over health care reform. Catherine has also written for the Boston Globe, U.S. News & World Report and The Daily Beast, and was Director of Content Development for the health practice at Edelman Public Relations for two years. Prior to joining BusinessWeek she was the London-based European Science Correspondent for Reuters News Service. She won the 2004 Business Journalist of the Year award from London’s World Leadership Forum, and in 2003 was the first recipient of the ACE Reporter Award from the European School of Oncology for her five-year body of work on cancer. She holds a bachelor’s degree in journalism from Boston University.