Novartis drug Afinitor is first treatment for advanced pancreatic NET to provide overall survival of more than 3.5 years in Phase III trial - Seite 2

Pancreatic NET originates from the islet cells of the pancreas and can grow aggressively[2]. It is uncommon and distinct from what is generally referred to as pancreatic cancer or pancreatic exocrine cancer[5]. The majority of patients with pNET have advanced disease at the time of diagnosis, meaning the cancer has spread to other parts of the body and has become more difficult to treat[2],[3].

"Novartis has more than 25 years of helping to advance NET care and this study, part of the largest global clinical program in NET, emphasizes our commitment to helping fulfill unmet needs for patients living with this disease," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "We are pleased to see that Afinitor provided more than 3.5 years of overall survival in patients with progressive, well-differentiated pNET, an advanced and aggressive cancer."

The presentation at ESMO 2014 is an analysis of the mature OS results. Results from the primary analysis, which focused on the progression-free survival (PFS) endpoint in which Afinitor more than doubled median PFS vs. placebo, were previously published in the New England Journal of Medicine (NEJM; February 2011).

About the study
RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study[1]. The core phase of the trial 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[1]. Patients who met the study entry criteria were randomized 1:1 to receive either everolimus 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in conjunction with BSC[1]. The primary endpoint was PFS, and the key secondary endpoints were OS and the safety and tolerability of everolimus[1].

Patients on placebo whose disease progressed during the core phase were allowed to cross over to open-label everolimus. In addition, when all patients were unblinded at the end of the core phase, those initially assigned to placebo were offered to switch to open-label everolimus and those in the everolimus arm could transition to open-label everolimus[1]. During the open label phase patients continued with treatment until disease progression was documented by the investigator[1]. At this point, patients discontinued the study drug and entered the follow-up period to be monitored monthly for survival information[1]. All patients initially randomized to placebo were included in the placebo arm results, even if they crossed over to everolimus therapy after progression or unblinding[1]. In total, 85% of patients in the placebo arm crossed over to everolimus during the course of the study[1].