Dr. Yuan on Tivantinib for Hepatocellular Carcinoma

RuiRong Yuan, MD, PhD, Head of Oncology Medical Affairs at Daiichi Sankyo, discusses a phase II trial that compared tivantinib (ARQ 197) to placebo for patients with hepatocellular carcinoma who failed one prior systemic therapy.

The international study enrolled 107 patients and randomized them 2:1 to receive tivantinib, an oral c-Met inhibitor, or placebo. Those who received tivantinib were initially given a 360 mg dose; this was reduced to 240 mg following the occurrence of high-grade neutropenia.

The trial found that progression-free survival (PFS) and time to progression (TTP) were significantly improved in those receiving tivantinib. Despite the initial toxicity observed with the 360 mg dose, the 240 mg dose demonstrated a manageable side effect profile. The trial also discovered that patients who tested positive for the MET mutation demonstrated a significantly longer PFS and TTP than those who did not.

Overall, results from this trial will help establish a larger phase III trial that further investigates tivantinib in hepatocellular carcinoma.