Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novartis drug Afinitor (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET), according to RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) study.
Subscribe to our email newsletter
RADIANT-3, a prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study, examined the efficacy and safety of everolimus plus BSC versus placebo plus BSC in 410 patients with advanced, low- or intermediate-grade pancreatic NET, also known as islet cell tumors, Novartis said.
The primary endpoint of RADIANT-3 is PFS.
Secondary endpoints include safety, objective response rate (confirmed according to RECIST), duration of response and overall survival.
Results from the trial showed that everolimus more than doubled median PFS from 4.6 to 11.0 months when compared with placebo and reduced the risk of cancer progression by 65% (hazard ratio [HR] =0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001) in patients with advanced pancreatic NET.
After 18 months, 34% of patients treated with everolimus (95% CI, 26 to 43) were alive and progression-free versus 9% of those treated with placebo (95% CI, 4 to 16), showing a more prolonged benefit for patients treated with everolimus.
The US Food and Drug Administration has granted everolimus priority review designation for the application of advanced NET of gastrointestinal (GI), lung or pancreatic origin based on results of RADIANT-3 and another Phase III trial, RADIANT-2.
Regulatory submissions for everolimus to treat this patient population are underway worldwide.