Pfizer Stops Sutent Phase III Trial

Pfizer has discontinued the SUN 1120 Phase III trial evaluating Sutent in combination with prednisone for advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) found that the combination of Sutent with prednisone was unlikely to improve overall survival when compared to prednisone alone. No new or unexpected safety issues were identified. Complete data from the trial is being analyzed and will be presented at an upcoming medical meeting.

“This planned interim analysis helped us determine that the combination of sunitinib with prednisone would not ultimately improve the overall survival of men with advanced stage, castration-resistant prostate cancer,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. “There is a great need for better therapies for prostate cancer and we are committed to working with basic scientists and clinical researchers to identify more effective treatments for this disease.”

Sutent 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). Pfizer is evaluating the potential role of Sutent for the adjuvant treatment of renal cell carcinoma in a Phase III trial.