Rare Disease Report

Phase 3 Hepatocellular Carcinoma Trial Fails

FEBRUARY 17, 2017
Andrew Black
A Phase 3 study of Daiichi Sankyo and ArQule’s tivantinib (ARQ 197), a designed treatment for MET-overexpressing hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival in patients.
The Phase 3 trial was a double-blind, placebo-controlled, randomized study evaluating tivantinib in comparison to best supportive care in 340 patients with MET-overexpressing, inoperable HCC intolerant to or previously-treated with systemic therapy.
Unfortunately, the study did not meet its primary endpoint. Full results from the trial will be presented at an upcoming medical conference.
The company has seen a string of negative results for this drug, but there was a ray of light in late 2014, when it posted a positive outcome in a phase 2 metastatic prostate cancer study after hitting the primary endpoint for progression-free survival compared to a placebo.
We will see what the next step for tivantinib is.

About tivantinib

Tivantinib is an investigational oral inhibitor of the MET receptor tyrosine kinase. Overexpression of the MET pathway is associated with poor outcomes in many cancers, including HCC, non-small cell lung cancer (NSCLC) and others.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a cancer that begins in the liver, usually in patients who have underlying chronic liver disease and scarring of the liver tissue (cirrhosis). Tumors progress with local expansion, intrahepatic spread, and distant metastases.
This type of cancer occurs more often in men than women. It is usually diagnosed in people age 50 or older.

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