A phase 3 study of sunitinib compared with placebo in the adjuvant treatment setting in patients at high risk for recurrent renal cell carcinoma (RCC) reached its primary end point of improving disease-free survival, Pfizer has announced.1
For this double-blind, S-TRAC study, more than 670 patients at high risk for recurrent RCC were randomly assigned to receive sunitinib or placebo for 1 year after surgery.
Adverse events observed with adjuvant sunitinib were consistent with the previously reported safety profile of sunitinib.
Full efficacy and safety data are expected to be presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark.
Sunitinib is an oral multi-kinase inhibitor that was initially granted approval by the U.S. Food and Drug Administration for the treatment of patients with advanced RCC. It is also indicated for imatinib-resistant or intolerant gastrointestinal stromal tumors, as well as advanced pancreatic neuroendocrine tumors.
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“Sutent has long been a standard of care for the treatment of advanced RCC, and has reached more than 250,000 patients across diagnoses around the world since its initial approval 10 years ago,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. “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.”
- Pfizer announces positive top-line results from phase 3 S-TRAC trial of Sutent® (sunitinib) as adjuvant therapy in patients at high risk of recurrent renal cell carcinoma. Pfizer website. http://press.pfizer.com/press-release/pfizer-announces-positive-top-line-results-phase-3-s-trac-trial-sutent-sunitinib-adjuv. Updated July 8, 2016. Accessed August 9, 2016.