Burlington, Mass.-based ArQule's and Tokyo, Japan-based Daiichi Sankyo's drug, tivantinib, failed to meet its primary endpoint of improving hepatocellular carcinoma patients' survival rate.
Researchers evaluated tivantinib in a randomized phase three study versus best supportive care. They wanted to test the drug's clinical effectiveness in MET-overexpressing, inoperable HCC-intolerant or previously-treated with systemic therapy patients.
Researchers treated 340 patients. The primary endpoint was overall survival with secondary endpoints including progression-free survival and safety.
The drug failed to meet its primary endpoint. Researchers will present the full study's detail at an unspecified upcoming scientific forum.
Paolo Pucci, CEO of ArQule, said in a press release the results were disappointing for patients, the researchers and the companies.