A Phase III study pitting adjuvant use of Pfizer’s Sutent against a placebo in patients with kidney cancer has met its primary endpoint of showing improved disease-free survival (DFS) in those taking the drug.
The S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer) is the first to test a tyrosine kinase inhibitor (TKI) to prolong DFS in the adjuvant setting, with the aim of lowering the risk of cancer recurrence in patients with early-stage disease.
Full data are yet to be revealed, but Mace Rothenberg, chief development officer of Oncology at Pfizer Global Product Development, said the firm believes the results “support the potential for Sutent to be a treatment option in a broader range of patients”.
The drugs giant also said it would be discussing the data with health authorities to determine an appropriate regulatory path forward for the drug in this setting.
Sutent (sunitinib malate) is approved for the treatment of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).
