Pfizer’s Sutent meets primary endpoint in phase 3 kidney cancer trial

Pfizer said that the S-TRAC study was the first RCC trial of a tyrosine kinase inhibitor (TKI) to extend DFS in the adjuvant setting.

The adjuvant therapy intends to help reduce the risk of cancer recurrence in patients with early-stage cancer.

The double-blind phase 3 S-TRAC trial randomized over 670 patients at high-risk of RCC recurrence to adjuvant sunitinib or placebo.

It included a global cohort and a China-specific cohort. The primary endpoint of the trial was DFS, which the study defined as the time between randomization and either recurrence, a secondary malignancy, or death.

The drug marker said the adverse events experienced for Sutent in the trial were consistent with its known safety profile.

Pfizer Global Product Development chief development officer of oncology Mace Rothenberg said: “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.

“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.”

Pfizer plans to meet with regulatory authorities to identify an appropriate regulatory path forward.

Sutent was approved in the US in 2006 to treat advanced RCC and has since become the most prescribed among oral medication approved for the condition. It is now approved in 119 countries.

Globally, over 250,000 patients have been treated with Sutent for advanced RCC, gastrointestinal tumors and pancreatic tumors.

Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.