New data continue to demonstrate the potential benefit of RAD001 (everolimus) for patients with advanced kidney cancer who have failed standard therapies.

Updated study findings from the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) study show that patients receiving RAD001 had no tumour growth for nearly five months vs. 1.9 months for patients receiving placebo (hazard ratio = 0.33 with 95% CI 0.25 to 0.43; p-value < 0.001). In addition, after more than 10 months of treatment with RAD001, 25% of patients still had no tumour growth.

The updated RECORD-1 data were presented today at the 33rd European Society for Medical Oncology (ESMO) Congress in Stockh olm, Sweden.
"These study results show the potential of RAD001 to continue working over an extended period of time in patients with advanced kidney cancer that progressed despite treatment with standard therapies," said Bernard Escudier, head of Immunotherapy and Innovative Therapy Unit, Gustave-Roussy Institute, Paris, France. "Based on these findings, I believe RAD001 should become part of the treatment paradigm for this patient population."

RAD001 has the potential to fill a currently unmet medical need and become the first approved therapy to demonstrate significant benefit in patients with advanced kidney cancer after failure of standard treatment, including Sutent (sunitinib) or Nexavar (sorafenib), or both.

Earlier this year, interim results from RECORD-1 presented at the American Society of Clinical Oncology Congress were used to submit regulatory applications for RAD001 (proposed brand name Afinitor) as a treatment for metastatic renal cell carcinoma (RCC). In the US, RAD001 was granted priority review by the US Food and Drug Administration. FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review time from ten to six months.

"We are encouraged by the continued benefit RAD001 provided to patients with advanced kidney cancer in this trial," said David Epstein, CEO and president of Novartis Oncology. "Novartis is committed to bringing this new, innovative therapy to market and to exploring the potential of RAD001 beyond this specific treatment setting."

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 cell division and tumour blood vessel growth. Data suggest RAD001 has clinical activity as a single agent or in combination with other therapies in multiple types of cancer, including pancreatic neuroendocrine tumours, breast, gastric, lung and lymphoma.

RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumour types. In cancer cells, RAD001 provides continuous inhibition of mTOR, a protein that acts as a central regulator of tumour cell division, cell metabolism and blood vessel growth.

Kidney, or renal cell, cancer accounts for two percent of all new cancer cases worldwide with occurrence rates rising steadily around the world. In RCC, cancer cells develop in the lining of the kidney's tubes and grow into a tumour.

Novartis AG provides healthcare solutions that address the evolving needs of patients and societies.