Astrazeneca to Halt Phase III Study With Zibotentan
From EquityBites (February 7, 2011)
7 February 2011 - Anglo-Swedish pharma major AstraZeneca plc (LON: AZN) (STO: AZN) said today it would halt the phase III study 15 with its product zibotentan as prostate cancer monotherapy as it is unlikely to meet the primary efficacy endpoints.
The primary endpoints of the trial, which includes patients with non-metastatic castrate resistant prostate cancer (CRPC), are progression-free survival and overall survival. After an early efficacy review by the Independent Data Monitoring Committee (IDMC), AstraZeneca has decided to stop the study as it is deemed unlikely to benefit patients.
Study 15 is part of a phase III programme, dubbed Enthuse, aimed at evaluating the efficacy and safety of zibotentan in extending survival in men with CRPC. The discontinuation of the trial marks the end of the zibotentan monotherapy programme.
In September 2010, the Enthuse study 14 with zibotentan as CRPC monotherapy did not show a significant improvement in the primary endpoint, namely overall survival.
Nevertheless, AstraZeneca will continue with the Enthuse study 33, testing zibotentan in combination with standard chemotherapy in more advanced metastatic CRPC, full results from which are expected in the second half of 2011.
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Posted: February 2011