Pfizer says its Sutent meets primary endpoint in Phase III trials for kidney cancer recurrence
pharmafile | July 11, 2016 | News story | Research and Development, Sales and Marketing | Kidney cancer, Pfizer, Stutent, drug trial
US pharma giant Pfizer (NYSE: PFE) said late-stage trials for its Sutent (sunitinib) met its primary endpoint as a treatment for kidney cancer.
Mace Rothenberg, chief development officer, oncology, Pfizer Global Product Development, 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 trials demonstrated the drug improved disease-free survival (DFS) in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery, the company said in a statement. The trial is the first RCC study of a tyrosine kinase inhibitor to prolong DFS in the adjuvant setting.
The study included over 670 patients at high risk of recurrent RCC, randomised to treatment with Sutent or placebo for one year. Pfizer said the trial had two cohorts, Global and China and that the current top-line analysis only includes data for the global cohort.
Sutent is an oral multi-kinase inhibitor that was approved in the US in 2006 for the treatment of advanced RCC. It is currently approved in 119 countries and is the most prescribed among oral medications approved for the treatment of advanced RCC in the US.
Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90% of all kidney cancers. At diagnosis, 30% of kidney cancer patients show signs of advanced disease and 15% to 25% of patients have metastatic RCC, where the cancer has spread to other parts of the body. About 338,000 new cases of kidney cancer are diagnosed worldwide each year, representing about 2% of all cancers.
Anjali Shukla
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