SUTENT has been a standard of care for the treatment of advanced RCC since it was approved more than a decade ago, and is now the first approved adjuvant treatment option for certain patients at high risk of recurrent RCC - the most common type of kidney cancer. The current treatment approach for RCC patients is surgery followed by observation, which is suboptimal for patients at high risk of recurrence.
“Today’s approval marks an important step forward for the treatment of adult patients who are at high risk of their renal cell carcinoma returning after surgery,” said Liz Barrett, global president and general manager, Pfizer Oncology. “Pfizer has been dedicated to advancing the science of RCC treatment for over a decade, and we are pleased to see this commitment continue to translate into meaningful options for patients.”
The S-TRAC trial was a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of SUTENT versus placebo in 615 patients with clear cell histology and high risk of recurrent RCC following nephrectomy. The study met its primary endpoint of improving DFS and the results were published by The New England Journal of Medicine in October 2016.
“Some patients who have undergone surgery for locally advanced RCC are at high risk of recurrence and often fear their disease returning,” said Daniel George, MD, study investigator and medical oncologist at Duke University Medical Center. “This adjuvant therapy is the first-of-its-kind and a remarkable clinical development for these patients who before today, have been restricted to a wait and see approach.”In the S-TRAC trial, the Hazard Ratio (HR) was 0.76 (95% CI: 0.59, 0.98) with a 2-sided p-value=0.03 in favor of SUTENT, representing a statistically significant 24% relative reduction in the risk of a DFS event. The median DFS was 6.8 years (95% CI: 5.8, not reached [NR]) in the SUTENT arm compared with 5.6 years (95% CI: 3.8, 6.6) in the placebo arm. At five years, the DFS rate for patients receiving SUTENT was 59.3% and 51.3% for placebo. This represents a persistent 8% absolute benefit.
No new safety signals were identified in the S-TRAC trial.
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