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news.Pfizer has discontinued the Sun 1120 Phase 3 trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen.
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Pfizer said that the discontinuation resulted from a scheduled interim analysis by an independent Data Monitoring Committee (DMC) which found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.
Sunitinib is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC), based on efficacy and safety data from large, randomised Phase 3 clinical trials.
Pfizer is evaluating the role of sunitinib for the adjuvant treatment of renal cell carcinoma in a Phase 3 trial.
Pfizer Oncology Business Unit Clinical Development and Medical Affairs senior vice president Mace Rothenberg said that the planned interim analysis helped them determine that the combination of sunitinib with prednisone would not ultimately improve the overall survival of men with advanced stage, castration-resistant prostate cancer.