Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved OS and PFS compared with placebo in a randomised phase 2 study in patients with high MET expression (MET-high) HCC previously treated with sorafenib. The aim of this phase 3 study was to confirm the results of the phase 2 trial. 340 patients were randomly assigned to receive tivantinib 120 mg twice daily (n=226) or placebo (n=114). At a median follow-up of 18.1 months (IQR 14.1-23.1), median OS was 8.4 months (95% CI 6.8-10.0) in the tivantinib group and 9.1 months (7.3-10.4) in the placebo group (HR 0.97; 95% CI 0.75-1.25; p=0.81).
(Rimassa L et al. – Lancet Oncology, May 2018)