ASCO presentation: A phase II study of tivantinib (ARQ-197) in second-line liver cancer.
What we know already: Top-line data from this phase II study were released in January. Liver cancer patients who progressed after first-line therapy were randomized 2:1 to receive tivantinib or a placebo.
The study met its primary endpoint with tivantinib demonstrating a 56 percent improvement in time to tumor regrowth compared to the placebo.
Key questions: Tivantinib dose was reduced mid-study due to reports of low blood cell counts in some patients. The ASCO presentation will provide details on how each tivantinib dose performed.
Key secondary endpoints in the study, most notably overall survival, will also be presented. [Placebo patients were allowed to cross over and receive tivantinib when their tumors started to grow again.]
Other notes: Arqule [ARQL 7.01 -0.19 (-2.64%) ]and partner Daiichi Sankyo are conducting a phase III study of tivantinib, a c-met inhibitor, in non-small cell lung cancer, with an interim analysis expected in the fourth quarter. A phase II study of tivantinib in colon cancer is also ongoing with results possible by year-end or in early 2013.