ArQule announced positive results from a randomized, double-blind, placebo-controlled Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer.

The Phase 2 study is being conducted in conjunction with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP). The study randomized 78 patients 2:1 to receive tivantinib 360mg twice daily or placebo. The primary objective of the trial is progression-free survival (PFS) an is designed to detect an improvement in the median PFS from 3–6 months with tivantinib treatment.

During a pre-planned analysis, researchers discovered that the trial met its primary endpoint of improving median PFS with tivantinib alone as compared to placebo. The results were highly statistically significant.

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The results of the trial are the subject of ongoing analyses. As final data emerge from this trial, ArQule and Daiichi Sankyo will discuss with the National Institutes of Health (NIH) the potential for additional trials in this indication. Tivantinib is currently in Phase 3 development.

Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase. When abnormally activated in cancer cells, MET plays roles in cell growth, survival, angiogenesis, invasion and metastasis.

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