Date: 2016-07-08
Type of information: Interim results
phase: 3
Announcement: interim results
Company: Pfizer (USA - NY)
Product: Sutent® (sunitinib)
Action
mechanism: kinase inhibitor/multi-kinase inhibitor. 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. It is currently approved in 119 countries and is the most prescribed among oral medications approved for the treatment of advanced RCC in the United States. Worldwide more than 250,000 patients across diagnoses have been treated with Sutent® in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).
Disease: patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Republic of Korea, Malaysia, Mexico, Poland, Slovakia, Spain, Sweden, Switzerland, Taiwan, UK, USA
Trial
details: 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. The primary objective for the Global cohort is to demonstrate an improvement in disease-free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant Sutent® vs. placebo after surgery. DFS is defined as the time interval from the date of randomization to the first date of recurrence or the occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. (NCT00375674)
Latest
news: * On July 8, 2016, Pfizer announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer), a Phase 3 study of Sutent® (sunitinib) versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) as determined by blinded independent central review in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. This top-line analysis comprises the Global cohort only. Results from the China cohort are not yet mature and will be reported at a later date. The S-TRAC trial is the first renal cell carcinomatrial of a tyrosine kinase inhibitor (TKI) 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. The adverse events observed for Sutent® in the S-TRAC trial were consistent with its known safety profile. Full efficacy and safety data will be submitted for presentation at the ESMO 2016 Congress in Copenhagen, 07-11 October 2016.
