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RAD001 More Than Doubles Time Without Tumor Growth After Failure of Standard Treatment in Patients With Advanced Kidney Cancer
Date:5/18/2008

- RECORD-1 trial shows RAD001 reduces risk of disease progression by 70% - RAD001 is first and only drug to show significant benefit after failure of approved therapies Sutent(R) or Nexavar(R),** with potential to address

unmet medical need - Once-daily oral RAD001 directly targets and continuously inhibits mTOR, a

protein that controls tumor cell division and blood vessel growth - RAD001 is currently being studied in multiple types of cancer including

neuroendocrine, breast, gastric, lung, and lymphoma

EAST HANOVER, N.J., May 19 /PRNewswire/ -- New data show RAD001 (everolimus) may provide an important new treatment option for patients with advanced kidney cancer who have failed standard therapies.

The interim study findings demonstrated that RAD001 significantly extended the time without tumor growth from 1.9 to 4 months and reduced the risk of cancer progression by 70% (hazard ratio = 0.30 with 95% CI 0.22 to 0.40; p- value < 0.0001). The study, RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily), will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, US on Saturday, May 31, 2008.

Earlier this year, an independent data monitoring committee stopped the RECORD-1 trial after interim results showed that patients receiving RAD001 experienced a significantly longer time without their cancer worsening compared to patients receiving placebo. The trial included patients whose cancer had stopped responding to approved treatments for renal cell carcinoma (RCC), such as Nexavar(R) (sorafenib) or Sutent(R) (sunitinib), or both.

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
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SOURCE Novartis Pharmaceuticals Corporation
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