ArQule’s lead candidate, the c-Met receptor tyrosine kinase inhibitor tivantinib, missed its primary progression-free survival (PFS) endpoint in a second Phase III study reported in as many months. The placebo-controlled JET-HCC study, carried out in Japan by ArQule’s partner Kyowa Hakko Kirin, failed to show that tivantinib therapy improved PFS in patients with c-Met diagnostic-high inoperable hepatocellular carcinoma who had previously received sorafenib therapy. ArQule and Kyowa Hakko Kirin agreed to their potentially $123 million deal for tivantinib in Japan, China, Korea, and Taiwan in 2007.

Commenting on failure of the JET-HCC study, Mitsuo Satoh, Ph.D., executive officer, vp, and head of R&D Division of Kyowa Hakko Kirin, said, “The result was disappointing, but Kyowa Hakko Kirin has gained great experience in oncology fields through this study.” Paolo Pucci, CEO of ArQule, added, “The results are disappointing as there is a need for a second-line HCC therapy in Japan… . I would like to thank our partner, Kyowa Hakko Kirin, and all the participants in this study.”

Last month ArQule and Daiichi Sankyo reported that tivantinib failed to meet its primary endpoint of overall survival in the Phase III METIV-HCC study in MET-overexpressing HCC patients with inoperable HCC who had previously been treated with systemic therapy. ArQule and Daiichi Sankyo inked their $75 million up-front global (excluding territories already licensed to Kyowa Hakko Kirin) deal for tivantinib and additional kinase inhibitor R&D in 2008. In 2012, the partners halted a Phase III study evaluating tivantinib in patients with nonsquamous NSCLC due to lack of efficacy.


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