Pfizer's Phase 3 S-TRAC Trial Of SUTENT Meets Primary Endpoint

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Pfizer Inc. PFE disclosed that its S-TRAC clinical study (Sunitinib Trial in Adjuvant Renal Cancer), a Phase 3 trial of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of enhancing disease-free survival (DFS). The company stated that this was as determined by blinded independent central review in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery.

Pfizer said the S-TRAC study was the first RCC trial of a tyrosine kinase inhibitor (TKI) to extend DFS in the adjuvant setting. The company added that the concept of adjuvant therapy was to help lower the risk of cancer recurrence in patients with early-stage cancer.

Pfize , Chief Development Officer, Oncology, Global Product Development, 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. 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."

The drug marker said the adverse events experienced for SUTENT in the S-TRAC trial were consistent with its known safety profile. The company added that full efficacy, as well as, safety data would be submitted for presentation at the ESMO 2016 Congress in Copenhagen, 07-11 October 2016.

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Posted In: BiotechNewsFDAGeneral
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