Investigational therapy extends progression-free survival in RCC

June 5, 2008

New data show that RAD001 (everolimus) may provide a new treatment option for patients with advanced kidney cancer who have failed standard therapies.

New data show that RAD001 (everolimus) may provide a new treatment option for patients with advanced kidney cancer who have failed standard therapies.

RAD001 significantly extended the time without tumor growth from 1.9 to 4 months and reduced the risk of cancer progression by 70% (HR=0.30; 95% CI: 0.22-0.40; p<.0001), according to interim study findings presented at the American Society of Clinical Oncology annual meeting in Chicago.

Earlier this year, an independent data monitoring committee stopped the REnal Cell cancer treatment of Oral RAD001 given Daily (RECORD-1) trial after interim results showed that patients receiving RAD001 experienced a significantly longer time without their cancer worsening than patients receiving placebo did. The trial included patients whose cancer had stopped responding to approved treatments for renal cell carcinoma.

RAD001 is a once-daily oral therapy that may offer a new approach to cancer treatment by continuously inhibiting the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells.

“This is the first study to show clinical benefit in patients with advanced kidney cancer who have experienced treatment failure with the most commonly used first-line therapies,” said principal investigator Robert J. Motzer, MD, of Memorial Sloan-Kettering Cancer Center in New York. “The results show RAD001 extended progression-free survival in patients, regardless of their prior treatments, risk status, age, or gender.”