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Pfizer halts phase III cancer trial

Pfizer has halted a phase III trial of its cancer drug Sutent in combination with prednisone for advanced castration-resistant prostate cancer

Pfizer has halted a phase III trial of its cancer drug Sutent (sunitinib malate) in combination with prednisone for advanced castration-resistant prostate cancer after an interim data analysis showed that the combination did not appear to be more effective than prednisone alone.

An independent Data Monitoring Committee evaluated data from the trial, which was testing the therapy in men whose disease had progressed despite docetaxel-based chemotherapy, and determined that the combination regimen was unlikely to improve overall survival compared to prednisone alone.

Pfizer said it is analysing the full data set from the trial and will present the results at an upcoming medical meeting. No new safety concerns were identified in the trial, the company noted, although serious hepatotoxicity has been observed in clinical trials and post-marketing experience.

Sutent is approved in the US for both advanced gastrointestinal stromal tumour and advanced/metastatic renal cell carcinoma. The drug, an oral multi-kinase inhibitor, is also in phase III clinical studies as an adjuvant treatment of renal cell carcinoma.

Pfizer announced in March that it had halted two late-stage clinical trials of Sutent in breast cancer due to a lack of efficacy, and the company called off a phase III study of Sutent in advanced colon cancer last year after the drug failed to show more efficacy than standard chemotherapy for the indication.

In conjunction with the latest Sutent news, Pfizer also released an update of its pipeline, reflecting the new development programmes it acquired as part of its acquisition of Wyeth. Pfizer said it has 118 programmes in phase I, compared to 133 phase I programmes at the start of this calendar year.  The figure reflects 25 programmes that are new or have advanced and 31 programmes that have been discontinued since January. 

Pfizer said it has 26 programmes in phase III and nine programmes in phase III registration, "as well as 27 biologics and four vaccines across all phases of development."

28th September 2010

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