publication date: Oct. 1, 2014

Pancreatic Neuroendocrine Tumors Afinitor Increases Overall Survival To 3.5 Years in Phase III Trial

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An analysis of mature overall survival data from a phase III trial showed that Afinitor increased median overall survival by 6.34 months compared to placebo, for a total of over 3.5 years in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology Congress in Madrid. Results from the primary analysis, which focused on progression-free survival, in which Afinitor (everolimus) more than doubled median PFS compared to placebo, were previously published in the New England Journal of Medicine.

Results from the trial, named RADIANT-3, showed a median OS of 44.02 months (95% CI: 35.61, 51.75) in patients treated with Afinitor plus best supportive care, and 37.68 months (95% CI: 29.14, 45.77) in the placebo arm.

The 6.34 month difference between the two arms was not statistically significant (HR 0.94; 95% CI: 0.73, 1.20; p=0.300). According to the drug’s sponsor, Novartis, a high crossover of patients from placebo to Afinitor (85 percent) likely contributed to the long median OS in the placebo arm of 37.68 months, and may have confounded the ability to detect a difference in the OS results.

“The median overall survival of 44 months for everolimus is unprecedented in controlled clinical trials for advanced progressive pancreatic neuroendocrine tumors,” said lead investigator James Yao, of MD Anderson Cancer Center. “The results affirm the importance of targeting key pathways involved in tumor growth, such as the mTOR pathway in advanced pNET.”

RADIANT-3 is a prospective, double-blind, … Continue reading CCL Sept – Pancreatic NET

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