Positive Top-Line Results Announced by Pfizer from Phase 3 S-TRAC Trial of SUTENT® (sunitinib) as Adjuvant Therapy in Patients at High Risk of Recurrent Renal Cell Carcinoma

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

July 8, 2016

Pfizer Inc. has announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant RenalCancer), a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. This S-TRAC trial is the first RCC trial of a tyrosine kinase inhibitor (TKI) to prolong DFS in the adjuvant setting. Adjuvant therapy can help lower the risk of cancer recurrence in patients with cancer at an early-stage.

“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. We look forward to sharing the detailed results of S-TRAC with the oncology community and discussing these data with health authorities to determine an appropriate regulatory path forward,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.

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