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After Tivantinib Phase III Flop, ArQule Shifts Focus To Earlier-Stage Assets

 
• By Emily Hayes

ArQule devotes investor call about tivantinib failure in MET-high liver cancer to its other pipeline candidates, including the FGFR inhibitor ARQ 087, which will enter pivotal testing in intrahepatic cholangiocarcinoma, a rare type of liver cancer, this summer.

ArQule Inc.is focused squarely on plans for early-to-mid-stage assets following the hard-to-explain failure of tivantinib, which is partnered with Daiichi Sankyo Co. Ltd., in the Phase III METIV-HCC study in second-line liver cancer with high expression of the biomarker MET.

The companies announced Feb. 17 in a joint statement that tivantinib failed to meet the overall survival primary endpoint in the Phase III study of the drug as a second-line therapy compared to best supportive care in 340 patients with MET-overexpressing liver cancer. ArQule had previously announced that it needed to reduce dosing in the trial for safety reasons, as a decline in white blood cells was reported

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