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news.Novartis has reported that an independent data monitoring committee stopped a major Phase III clinical trial of the investigational drug everolimus after interim results showed significantly better progression-free survival in patients with advanced kidney cancer who received everolimus compared to placebo.
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The committee stopped the trial of more than 400 patients conducted in 12 countries because the study met its primary endpoint. Safety findings in the study were manageable and consistent with prior Phase II studies. The interim findings are being shared with investigators to allow them to offer everolimus to patients remaining on placebo. Everolimus may fulfill an unmet medical need for patients with advanced renal cell cancer (RCC) who currently have no approved treatment options.
Everolimus is a once-daily oral therapy that offers a new approach to cancer treatment by inhibiting 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 for RCC, such as Nexavar (sorafenib) or Sutent (sunitinib) or both. In addition, prior therapy with Avastin (bevacizumab) and interferon was allowed. Worldwide regulatory filings for this indication beginning with US and EU will occur in the second half of 2008.
Daniel Vasella, chairman and CEO of Novartis, said: “Everolimus is a targeted therapy which is being studied in multiple tumor types, and could provide significant benefit to patients suffering from cancer.”