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Novartis's Afinitor Fails to Slow Rare Form of Pancreatic Cancer in Trial

http://www.bloomberg.com/news/2010-10-11/novartis-s-afinitor-fails-to-slow-rare-form-of-pancreatic-cancer-in-trial.html

By Eva von Schaper - Oct 11, 2010

Novartis AG’s Afinitor kidney cancer drug didn’t slow a rare form of pancreatic cancer in a late- stage trial, researchers said.

Afinitor combined with the company’s Sandostatin drug failed to stop neuroendocrine tumors, or NET, from growing, Basel, Switzerland-based Novartis said in an e-mailed statement today. The research was presented at the European Society for Medical Oncology meeting today in Milan.

Afinitor is approved as a treatment for patients with advanced kidney cancer who aren’t helped by standard therapies. The drug works by blocking mTOR, a cell messenger that controls cell growth and reproduction.

“A key goal of treating patients with advanced NET is to extend time without tumor growth,” Marianne Pavel, a professor of medicine at the Charité Hospital in Berlin, said in the release.

The trial, dubbed RADIANT-2, included 429 patients with advanced NET who received either Afinitor or Afinitor plus Sandostatin. The most frequent side effects were stomatitis, rash, fatigue and diarrhea. The drug failed to reach its goal of extending progression-free survival, a common measure of a drug’s efficacy.

The tumors grow in the neuroendocrine system, which consists of cells that have the properties both of nerve cells and of hormone-making cells. The growths can be found throughout the body, according to the American Cancer Society.

Novartis estimates that 5 patients in 100,000 are diagnosed with NET every year.

Another study, RADIANT-3, showed that Afinitor, also known as everolimus, kept advanced pancreatic neuroendocrine tumors at bay for 11 months, more than twice as long as for patients given the best supportive care treatment plus placebo, Novartis said in June. The company plans to seek regulatory approval this year for the use of Afinitor against pancreatic neuroendocrine tumors, Novartis said.