US-based pharmaceutical company Pfizer has reported positive top-line results of the Phase III S-TRAC clinical trial of Sutent against placebo to treat patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery.
Sutent (sunitinib malate) is a multi-kinase inhibitor that is orally administered and indicated to be used for RCC, imatinib-resistant or imatinib-intolerant gastrointestinal stromal tumours (GIST) and advanced pancreatic neuroendocrine tumours (pNET).
The Phase III S-TRAC trial is a randomised, double-blind study of adjuvant Sutent against placebo.
More than 670 patients who were at high risk of recurrent RCC were involved in the trial and administered with Sutent or placebo for one year.
The global cohort of the trial was primarily focused to exhibit an improved disease-free survival (DFS) within patients at high risk of recurrent RCC, randomly assigned to adjuvant Sutent compared to placebo post surgery.
Pfizer global product development chief development officer Mace Rothenberg said: “We believe the results from the S-TRAC trial support the potential for Sutent to be a treatment option within a broader range of patients.
“We look forward to sharing the detailed results of S-TRAC with the oncology community and discussing this data with health authorities to determine an appropriate regulatory path forward.”
The global cohort of the trial has met its primary endpoint of achieving an improved DFS, which has been determined by a blinded independent central review in patients with RCC.