Afinitor is approved for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
The Radiant-3 study showed that Everolimus extended the median time without tumor growth from 4.6 to 11 months when compared with placebo. The data also demonstrated that Everolimus reduced the risk of cancer progression by 65%.
Novartis said that the primary endpoint of Radiant-3 is progression-free survival, while the secondary endpoints include safety, objective response rate and overall survival. Additionally, in the study, Everolimus had a safety profile consistent with previous studies of this drug.
James Yao, associate professor of medicine at The University of Texas MD Anderson Cancer Center, said: “It’s encouraging to see that by targeting the mTOR pathway, treatment with Everolimus can provide a progression-free survival advantage over placebo in patients with advanced pancreatic NET.
“These results further validate earlier trials and demonstrate the benefit Everolimus can provide to these patients.”
Herve Hoppenot, president of Novartis Oncology, said: “Our commitment to patients with advanced NET continues with the Radiant trial program.”