ArQule’s Lead Cancer Drug Fails Another Clinical Trial

Xconomy Boston — 

More bad news for ArQule’s (NASDAQ: 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.