ArQule’s lead drug tivantinib flops again in PhIII liver cancer study

ArQule CEO Paolo Pucci

ArQule and Daiichi Sankyo’s tivantinib has come up short in another Phase III study.

Five years after the biotech’s lead drug flopped in a late-stage study for non-small cell lung cancer, investigators said that the same fate befell its Phase III for hepatocellular carcinoma, a common form of primary liver cancer. The drug flunked the primary endpoint on overall survival.

The drug also failed a Phase II in colorectal cancer in 2013.

ArQule’s stock $ARQL never recovered from its fall off a cliff in 2012, after the first late-stage disaster. And it plunged into penny stock territory in pre-market trading, free falling 38%.

“HCC is a disease with high unmet need, especially in the second-line setting, so these results are disappointing for the patients as well as the investigators and the companies,” said ArQule CEO Paolo Pucci.

Investigators recruited 340 patients for this study, looking to see its impact on subjects identified with MET-overexpressing cases. The therapy is designed to inhibit c-MET receptor tyrosine kinase.

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