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Another setback for TAK-700

Paul Edwards

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Orteronel (TAK-700) is an androgen synthesis inhibitor. It selectively inhibits the enzyme CYP17A1..


A paper presented yesterday at the American Society for Clinical Oncology (ASCO) meeting reported the results of a second large Phase III clinical trial of Orteronel + Prednisone in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer.


In the trial, whilst treatment with Orteronel + Prednisone was shown to delay the onset of radiographic progression, there was no overall survival benefit.   Orteronel + Prednisone was also associated with a number of significant side effects compared to placebo + prednisone; 30% of patients on the Orteronel + Prednisone arm of the trial discontinued due to adverse side effects.


A previous Phase III clinical trial of Ortoronel + Prednisone for the treatment of men with progressive, metastatic, castration-resistant prostate cancer who had been previously treated with at least one cycle of docetaxel-based chemotherapy also showed no overall survival benefit.


The New Prostate Cancer Infolink commented: "This is clearly a second major setback for the potential of Orteronel as a potential treatment for prostate cancer, and it is hard to see that the developers will pursue the potential of this product for much longer.”


Given that other drugs recently approved by the American Food and Drug Administration (FDA) such as Zytiga and Xtandi have demonstrated an overall survival benefit, it is unlikely that Orteronel would receive FDA approval on the current evidence.


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