The preliminary data, which are from an interim analysis of Wyeth’s ongoing phase III clinical trial of temsirolimus (CCI-779) in advanced renal cell carcinoma (RCC), showed that single-agent therapy with temsirolimus significantly increased overall survival as a first-line treatment of patients with advanced disease and poor risk features compared to interferon-alpha.
This open-label, randomized, phase III trial involved 626 patients with advanced RCC and poor risk features who had received no prior systemic therapy. The primary endpoint of the study was overall survival.
In the trial, patients who were treated with temsirolimus, a specific mTOR inhibitor, alone experienced a 3.6-month, or 49%, increase in median overall survival time, compared with patients treated with interferon-alpha alone (10.9 months versus 7.3 months).
“Advanced renal cell carcinoma is a particularly difficult form of cancer to treat, and despite recent advances, patients still have few treatment options,” commented Dr Gary Hudes, director of the genitourinary malignancies program at Fox Chase Cancer Center in Pennsylvania. “The ability to improve survival for these patients with advanced renal cell carcinoma and poor-risk features by three and a half months is quite an achievement, and shows that mTOR inhibition may be a viable approach in this disease area.”