NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) announced the Sunitinib Trial in Adjuvant Renal Cancer, a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival in patients with renal cell carcinoma who are at high risk for recurrence after surgery. The adverse events observed for SUTENT in the S-TRAC trial were consistent with its known safety profile.
SUTENT (sunitinib malate) is an oral multi-kinase inhibitor that was approved in the United States in 2006 for the treatment of advanced renal cell carcinoma. The S-TRAC trial is a randomized double-blind Phase 3 trial of adjuvant SUTENT vs. placebo in more than 670 patients at high risk of recurrent renal cell carcinoma. Patients were on SUTENT or placebo for one year. The trial has two cohorts: Global and China.
Mace Rothenberg, Chief Development Officer, Oncology, Pfizer Global Product Development, said: 'We believe the results from the S-TRAC trial support the potential for SUTENT to be a treatment option in a broader range of patients.'
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