Tivantinib (ArQule/Daiichi Sankyo/Kyowa Hakko Kirin) is an orally available small molecule inhibitor of the hepatocyte growth factor (HGF) receptor, c-MET. Aberrant expression of HGF/c-MET promotes angiogenesis, cancer cell proliferation, and metastasis via growth factor receptors and other oncogenic pathways, and has been observed in many tumor types including hepatocellular cancer.
ArQule/Daiichi Sankyo/Kyowa Hakko Kirin are positioning tivantinib as a second-line therapy for advanced metastatic hepatocellular cancer (HCC) patients who have documented overexpression of c-MET (MET diagnostic-high). If approved, tivantinib will not benefit from uptake in the larger proportion of second-line HCC patients who are not MET diagnostic-high. However, strong Phase II efficacy data suggest tivantinib has an opportunity to become the standard of care for the MET diagnostic-high subpopulation, so sales could still be high. There may be a future scenario where tivantinib would come under intense competitive pressure from Cometriq (cabozantinib; Exelixis/Swedish Orphan Biovitrum), which is also a c-MET inhibitor targeting the second-line setting.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 tivantinib : Hepatocellular cancer
LIST OF FIGURES
7 Figure 1: Phase II results for tivantinib in advanced hepatocellular cancer
8 Figure 2: Tivantinib’s SWOT analysis for hepatocellular cancer
9 Figure 3: Datamonitor Healthcare’s drug assessment summary for tivantinib in hepatocellular
9 Figure 4: Datamonitor Healthcare drug assessment summary for tivantinib in hepatocellular
LIST OF TABLES
4 Table 1: Tivantinib – drug profile
6 Table 2: Phase III pivotal studies of tivantinib in hepatocellular cancer
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