Renal Cell Carcinoma Drug Improves Survival in Phase 3 Trial

A phase 3 trial showed positive top-line results of sunitinib malate (Sutent) as adjuvant therapy in patients at high risk of recurrent renal cell carcinoma (RCC).

Sutent is an oral multi-kinase inhibitor approved by the FDA in 2006 for the treatment of advanced RCC, a form of kidney cancer that accounts for about 90% of all kidney cancers. The randomized, double-blind, phase 3 trial S-TRAC examined adjuvant Sutent compared with placebo in more than 670 patients at high risk of recurrent RCC.

The trial consisted of 2 cohorts, Global and China, with participants receiving Sutent or placebo for 1 year. In the Global cohort, patients were randomized to receive either adjuvant Sutent or placebo after surgery.

The study was assessed by a blinded independent central review to determine the primary endpoint of improvement in disease-free survival (DFS) in patients at high risk of recurrent RCC after surgery. DFS was defined as the time interval from the date of randomization to the first date of recurrence, occurrence of a secondary malignancy, or death.

“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. We look forward to sharing the detailed results of S-TRAC with the oncology community and discussing these date with health authorities to determine an appropriate regulatory path forward.”

The top-line analysis was comprised of only the Global cohort, with results from the China cohort coming at a later date. The S-TRAC trial is the first RCC trial of a TKI to prolong DFS in the adjuvant setting.