ArQule falls as Kyowa suspends tivantinib enrollment

ArQule Inc. (NASDAQ:ARQL) fell $1.24 (19%) to $5.46 on Wednesday after partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) suspended enrollment in the Phase III ATTENTION trial of tivantinib in non-small cell lung cancer following an imbalance of interstitial lung disease between treatment arms. The double-blind, Asian trial is comparing tivantinib plus Tarceva erlotinib to Tarceva alone in 460 EGFR wild-type patients with locally advanced or metastatic, non-squamous NSCLC who received 1-2 prior systemic cancer therapies. Patients already enrolled will continue to be treated during a review of the events by the trial's independent safety committee.

Neither ArQule nor Kyowa could be reached for details. Tarceva's U.S. label warns that interstitial lung disease-like events, including deaths, have been "infrequently reported" with the small molecule inhibitor of EGFR tyrosine kinase activity. Tivantinib is a small molecule inhibitor of c-Met receptor tyrosine kinase. ...