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news.Pfizer has unveiled results from the Phase 3 S-TRAC clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer) investigating SUTENT (sunitinib) as adjuvant therapy.
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The trial showed SUTENT extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of renal cell carcinoma (RCC) (HR 0.761; P=0.030 [95% CI: 0.594-0.975]).
These results will be presented today during a Presidential Symposium (Abstract #LBA11_PR) at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology being held in Copenhagen, Denmark. The results have also been published online by The New England Journal of Medicine.
Adjuvant therapies are treatments that can be given to reduce the likelihood of the cancer returning after initial treatment such as surgery.
de Bordeaux Hôpital Saint André lead investigator Alain Ravaud said: “We are encouraged by the S-TRAC results because this is the first clinical trial to show increased disease-free survival in the adjuvant setting for RCC.
“These data are promising for RCC patients as there are no effective treatments currently available in this setting.”
The results from the S-TRAC trial showed that after one year of treatment, the median time until disease recurrence in participants treated with SUTENT after surgery was 6.8 years compared with 5.6 years for patients treated with placebo as assessed by independent central review, resulting in an overall risk reduction of 24%. At the time of the analysis, overall survival (OS) data was immature.
Based on the results of S-TRAC, Pfizer is in discussions with global regulatory authorities to determine potential next steps.
Pfizer Global Product Development Oncology chief development officer Mace Rothenberg said: “For the past 10 years, Pfizer has been a leader in developing new treatments for patients with kidney cancer, and SUTENT has been the most widely prescribed first line treatment for thousands of patients with advanced RCC around the world.
“The results of S-TRAC suggest that SUTENT has the potential to extend this benefit by reducing the risk of recurrence in patients who have undergone complete surgical removal of their kidney cancer and are at high risk of cancer recurrence.”
The adverse events seen in the trial were consistent with SUTENT’s known safety profile. The most common adverse reactions (>20%) are fatigue, asthenia, and fever. Grade ≥3 adverse events were more frequent with SUTENT (62.1%) vs. placebo (21.1%). No deaths occurred due to treatment toxicity.
SUTENT is an oral cancer medication that was first approved in the United States in 2006 for the treatment of advanced RCC.
It is currently approved in 119 countries.i 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).ii SUTENT is not approved in the adjuvant setting.
About Renal Cell Carcinoma (RCC)
Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 percent of all cancers.iii Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases.iv
About S-TRAC
The S-TRAC trial was a randomized double-blind Phase 3 trial of adjuvant SUTENT vs. placebo in 615 patients with local, resected RCC at high risk of recurrence. Patients received 50 mg/d of SUTENT or placebo in a four weeks on, two weeks off schedule for one year until disease recurrence, occurrence of secondary malignancy, significant toxicity or consent withdrawal.
The primary objective was to demonstrate an improvement in DFS by blinded independent central radiologic review. DFS was 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 referred to relapse of the primary tumor locally or at metastatic sites. The S-TRAC trial has two cohorts: Global and China. These results are from the Global cohort only. Results from the China cohort are not yet mature and will be reported at a later date.
About SUTENT (sunitinib malate)
SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.
Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.
SUTENT is indicated for the treatment of advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.