Pfizer Inc. announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer), a phase 3 study of Sutent versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) as determined by blinded independent central review in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. The S-TRAC trial is the first RCC trial of a tyrosine kinase inhibitor (TKI) to prolong DFS in the adjuvant setting. The concept of adjuvant therapy is to help lower the risk of cancer recurrence in patients with early-stage cancer.

“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,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “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 adverse events observed for Sutent in the S-TRAC trial were consistent with its known safety profile. Full efficacy and safety data will be submitted for presentation at the ESMO 2016 Congress in Copenhagen, 07-11 October 2016.

Sutent (sunitinib malate) is an oral multi-kinase inhibitor that was approved in the United States 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 United States. Worldwide more than 250,000 patients across diagnoses have been treated with Sutent in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).

Pfizer is a leader in advanced RCC treatment with several approved therapies that have contributed to the treatment for patients with advanced RCC worldwide.

The S-TRAC trial is a randomized double-blind phase 3 trial of adjuvant Sutent vs. placebo in more than 670 patients at high risk of recurrent RCC. Patients were on Sutent or placebo for one year. The trial has two cohorts: Global and China.

The primary objective for the Global cohort is to demonstrate an improvement in disease-free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant Sutent vs. placebo after surgery. DFS is defined as the time interval from the date of randomization to the first date of recurrence or the occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.

This top-line analysis comprises the Global cohort only. Results from the China cohort are not yet mature and will be reported at a later date.

Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 per cent of all kidney cancers. Early stage renal cancers tend to have a better prognosis, while advanced cancers have a worse prognosis. At diagnosis, 30 per cent of kidney cancer patients show signs of advanced disease and 15 to 25 per cent of patients have metastatic RCC, where the cancer has spread to other parts of the body. Approximately 338,000 new cases of kidney cancer are diagnosed worldwide each year, representing approximately 2 percent of all cancers. Patients with advanced RCC have five-year survival rates of approximately 16 per cent.

The most common adeverse reactions occurring in =20 per cent of patients receiving  Sutent for treatment-naïve metastatic RCC (all grades, vs IFNa) were diarrhea (66 per cent vs 21 per cent), fatigue (62 per cent vs 56 per cent), nausea (58 per cent vs 41 per cent), anorexia (48 per cent vs 42 per cent), altered taste (47 per cent vs 15 per cent), mucositis/stomatitis (47 per cent vs 5 per cent), pain in extremity/limb discomfort (40 per cent vs 30 per cent), vomiting (39 per cent vs 17 per cent), bleeding, all sites (37 per cent vs 10 per cent), hypertension (34 per cent vs 4 per cent), dyspepsia (34 per cent vs 4 per cent), arthralgia (30 per cent vs 19 per cent), abdominal pain (30 per cent vs 12 per cent), rash (29 per cent vs 11 per cent), hand-foot syndrome (29 per cent vs 1 per cent), back pain (28 per cent vs 14 per cent), cough (27 per cent vs 14 per cent), asthenia (26 per cent vs 22 per cent), dyspnea (26 per cent vs 20 per cent), skin discoloration/yellow skin (25 per cent vs 0 per cent), peripheral edema (24 per cent vs 5 per cent), headache (23 per cent vs 19 per cent), constipation (23 per cent vs 14 per cent), dry skin (23 per cent vs 7 per cent), fever (22 per cent vs 37 per cent), and hair color changes (20 per cent vs <1 per cent). The most common grade 3/4 ARs (occurring in =5per cent of patients with RCC receiving Sutent vs IFNa) were fatigue (15 per cent vs 15 per cent), hypertension (13 per cent vs <1 per cent), asthenia (11 per cent vs 6 per cent), diarrhea (10 per cent vs <1 per cent), hand-foot syndrome (8 per cent vs 0 per cent), dyspnea (6 per cent vs 4 per cent), nausea (6 per cent vs 2 per cent), back pain (5 per cent vs 2 per cent), pain in extremity/limb discomfort (5 per cent vs 2 per cent), vomiting (5 per cent vs 1 per cent), and abdominal pain (5 per cent vs 1 per cent).