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AstraZeneca Zibotentan Phase III Study 14 fails to meet primary endpoint

AstraZeneca's randomised, placebo controlled Phase III Study 14 of Zibotentan, failed to show improvement in primary endpoint of overall survival (OS) in men with metastatic castration resistant prostate cancer (CRPC).

Zibotentan is a novel once daily tablet and works by blocking the endothelin pathway.

The Phase III study assessed Zibotentan 10mg added to standard of care treatment in 594 patients with metastatic CRPC.

In addition to Study 14, Astrazeneca has two other studies in the ENTHUSE trial programme with Zibotentan in different CRPC settings.

Astrazeneca said that currently it has no plans for regulatory filings for Zibotentan now.