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news.ArQule and Daiichi Sankyo have announced positive Phase 2 study results for Tivantinib, the selective MET inhibitor, in previously treated hepatocellular carcinoma (HCC).
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The 107 patients, with unresectable HCC and had disease progression after first-line therapy or were unable to tolerate the first-line therapy, were randomized in the placebo-controlled, double-blinded study.
Patients were randomized to receive tivantinib at 360mg twice daily or 240mg twice daily or placebo (2:1 tivantinib:placebo).
The time to progression (TTP) in the intent to treat (ITT) population was the primary endpoint of the trial.
A disease control rate (DCR), progression free survival (PFS), overall survival (OS), as well as safety for the ITT population and pre-defined MET-high or MET-low cohorts were other study endpoints.
Daiichi Sankyo senior executive officer and R&D global head Glenn Gormley said, "The strong overall survival results among HCC patients in this trial whose tumors were MET-high reinforce this previous research that defines MET as a critical pathway in cancer as well as the activity of tivantinib as a MET inhibitor."
The study reported statistically significant 56% improvement as compared to placebo was seen in TTP in the ITT population (hazard ratio [HR] = 0.64; log rank p-value = 0.04).
In the MET-high cohort, there were also statistically significant improvements in TTP, PFS and OS, the company said.