ArQule Setback Increases Risk and Discount Rates for Forward Revenue

ArQule Inc. (NASDAQ:ARQL), co-developer of the tivantinib cancer treatment, received word from its Japanese partner Kyowa Hakko Kirin Co., that Kyowa has suspended patient enrollment in Asian trials due to safety concerns. An independent Safety Review Committee (SRC) suspects that the drug, which is in Phase III testing for non-small cell lung cancer (NSCLC),  could be causing interstitial lung disease (ILD) in trial subjects. There has been an imbalance in cases of ILD in the two arms of the ATTENTION study (tivantinib vs. placebo). Patients already undergoing treatment will continue with the trial until further review can be completed. The same trial in the West  (U.S. Canada, and Australia), called MARQUEE, has not revealed safety issues and already completed recruitment. Management guides for interim data by year’s end, with data from ATTENTION in 2013. ArQule develops the product with Daiichi Sankyo (OTC:DSNKY) in the U.S. (more…)