Positive Phase 3 Results Reported for Sunitinib (Sutent) in Patients at Risk of Recurrent Renal Carcinoma

Treatment prolongs disease-free survival

The Sunitinib Trial in Adjuvant Renal Cancer (S-TRAC), a phase 3 study of sunitinib (Sutent, Pfizer) versus placebo in the adjuvant setting, has met its primary endpoint of improving disease-free survival (DFS) in patients with renal cell carcinoma (RCC) who were at high risk for recurrence after surgery. S-TRAC is the first RCC trial of a tyrosine kinase inhibitor to prolong DFS in the adjuvant setting. The concept of adjuvant therapy is to help lower the risk of cancer recurrence in patients with early-stage cancer.

Sunitinib malate is an oral multi-kinase inhibitor that was approved in the United States in 2006 for the treatment of patients with advanced RCC. It is the most-prescribed oral medication approved for the treatment of advanced RCC in the U.S. Worldwide, more than 250,000 patients have been treated with sunitinib in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST), and advanced pancreatic neuroendocrine tumors (pNET).

S-TRAC was a randomized, double-blind study of adjuvant sunitinib versus placebo in more than 670 patients at high risk of recurrent RCC. The patients received either sunitinib or placebo for one year. The trial had two cohorts: global and China.

The study’s primary objective for the global cohort was to demonstrate an improvement in DFS in patients at high risk of recurrent RCC randomly assigned to receive adjuvant sunitinib or placebo after surgery. DFS was defined as the period from the date of randomization to the first date of recurrence or to the occurrence of a secondary malignancy or death. Recurrence was defined as relapse of the primary tumor in situ or at metastatic sites.

Source: Pfizer; July 8, 2016.