RAD001 extends progression-free survival in advanced renal cancer pts

EAST HANOVER, New Jersey—An independent data monitoring committee stopped a phase III clinical trial of the investigational mTOR inhibitor everolimus (RAD001) after interim results showed significantly better progression-free survival in patients with advanced kidney cancer who received the drug, compared with placebo.

Complete results of the RECORD-1 trial have been submitted as a late-breaking abstract for presentation at the 2008 ASCO annual meeting.

The committee stopped the trial of more than 400 patients conducted in 12 countries because it met its primary endpoint. The interim findings are being shared with investigators to allow them to offer everolimus to patients remaining on placebo.

Everolimus is a once-daily oral therapy that inhibits the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells. The trial included patients who had their cancer worsen despite receiving approved treatments such as sorafenib(Drug information on sorafenib) (Nexavar) or sunitinib (Sutent) or both. In addition, prior therapy with bevacizumab(Drug information on bevacizumab) (Avastin) and interferon was allowed.

Safety findings in the study were manageable and consistent with prior phase II studies, Novartis said in a news release.

“Everolimus has the potential to greatly help patients with kidney cancer, especially in advanced stage who, up to now, have had no treatment options, as patients in the clinical trial on everolimus experienced a significantly longer period of time during which their cancer did not progress,” said Daniel Vasella, chair and CEO of Novartis. “Everolimus is a targeted therapy that is being studied in multiple tumor types.”