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11 October 2010

Novartis reports Afinitor neuroendocrine tumour data, filings expected this year

Novartis reported Monday data at the European Society for Medical Oncology congress from a late-stage trial in which Afinitor (everolimus) extended median progression-free survival (PFS) in patients with advanced neuroendocrine tumours (NET) when compared to placebo. The Swiss company noted that results from the RADIANT-2 study, along with those from another Phase III trial, will form the basis of worldwide regulatory filings this year for the mTOR inhibitor.
The RADIANT-2 study enrolled 429 patients with advanced NET who were randomised to receive Sandostatin LAR (octreotide acetate) in combination with either once-daily Afinitor or placebo. Although the trial failed to meet its primary endpoint of PFS, Novartis said data showed patients treated with Afinitor had a "clinically meaningful" increase in median PFS of 16.4 months, compared with 11.3 months for those who took placebo.
Lead researcher Marianne Pavel commented that the study was designed to test "for an improvement of at least 4.5 months compared to [Sandostatin] LAR and were pleased with the resulting 5.1 month difference." The drugmaker also indicated that after adjusting for "imbalances in the treatment arms," Afinitor was shown to significantly reduce the risk of disease progression by 40 percent compared to placebo.
The company also presented data at ESMO from the < href="http://www.firstwordplus.com/Fws.do?articleid=CA1B497D623442D4A570A45D338B85E4">previously reported RADIANT-3 trial, which demonstrated that Afinitor extended the median time without tumour growth from 4.6 to 11 months when compared with placebo in patients with advanced pancreatic NET.
Afinitor was approved last year in both the US and Europe as a treatment for patients with advanced renal cell carcinoma. Analysts expect that yearly sales of the drug could reach $1 billion by 2014.

Reference Articles
Novartis's Afinitor fails to slow rare form of pancreatic cancer in trial - (Bloomberg)
Phase III Novartis data show potential benefit of Afinitor plus Sandostatin LAR in patients with advanced neuroendocrine tumors - (Novartis)
Novartis to file Afinitor after Phase III study data (free preview) - (The Wall Street Journal)
Novartis drug helps rare tumors, filing this year - (Yahoo!News)

**Published in "First Word"

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