Results from a phase 3 trial presented at the European Society for Medical Oncology 2014 Congress in Madrid showed overall survival of more than 3.5 years in patients with advanced and progressive pancreatic neuroendocrine tumors treated with everolimus, according to a press release.
“The median overall survival of 44 months for everolimus (Afinitor, Novartis) is unprecedented in controlled clinical trials for advanced progressive pancreatic neuroendocrine tumors (pNET),” James Yao, MD, University of Texas MD Anderson Cancer Center, said in the release. “The results affirm the importance of targeting key pathways involved in tumor growth, such as the mTOR [mammalian target of rapamycin] pathway in advanced pNET.”
According to the release, participants in the RADIANT-3 trial had well-differentiated advanced and progressive pNET and received everolimus tablets plus best supportive care or placebo plus best supportive care. Median overall survival (OS) was 44.02 months (95% CI, 35.61-51.75) with everolimus compared with 37.68 months (95% CI, 29.14-45.77) with placebo. While the difference did not reach statistical significance (HR=0.94; 95% CI, 0.73-1.2), an 85% crossover of patients from placebo to everolimus “likely contributed to the long median OS in the placebo arm … and may have confounded the ability to detect a difference in the OS results,” the release said. The safety profile was consistent with past observations; the most common adverse events included stomatitis, rash, diarrhea and fatigue.
The results will be submitted to health authorities for inclusion in Afinitor prescribing information, the release said.
For more information:
Oberg K. Abstract #1132O. Presented at: European Society for Medical Oncology 2014 Congress; Sept. 26-30; Madrid, Spain.
Disclosure: See the abstract for a full list of relevant financial disclosures.