Novartis reports positive Phase III trial results of pancreatic cancer drug Afinitor


Novartis has reported final results from a Phase III trial of Afinitor (everolimus) tablets plus best supportive care (BSC) compared to placebo plus BSC in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumours (pNET).

The company noted that the RADIANT-3 trial met the secondary endpoint of overall survival.

Results from the trial showed a median OS of 44.02 months in the everolimus treatment arm and 37.68 months in the placebo arm, while the 6.34 month difference between the two arms was not statistically significant.

The University of Texas MD Anderson Cancer Centre lead investigator Dr James Yao said: "The median overall survival of 44 months for everolimus is unprecedented in controlled clinical trials for advanced progressive pancreatic neuroendocrine tumours.

"The company noted that the RADIANT-3 trial met the secondary endpoint of overall survival."

"The results affirm the importance of targeting key pathways involved in tumour growth, such as the mTOR pathway in advanced pNET."

The trial showed that the safety profile was consistent with that observed for everolimus in advanced pancreatic NET and no unexpected or new safety concerns were identified at the time of this analysis, indicating that longer term treatment with everolimus continues to provide a positive benefit-risk ratio for patients.

The most commonly reported adverse events (AEs) for everolimus compared to placebo during the core phase of the trial were stomatitis, rash, diarrhoea and fatigue.

The most common AEs reported with everolimus during this follow-up phase were stomatitis, diarrhoea and rash.

Novartis Oncology Development and Medical Affairs global head Alessandro Riva said: "Novartis has more than 25 years of helping to advance NET care and this study, part of the largest global clinical program in NET, emphasises our commitment to helping fulfil unmet needs for patients living with this disease.

"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 core phase of the prospective, double-blind, randomised, parallel group, placebo-controlled, multicentre RADIANT-3 trial evaluated 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 tumours.

Patients who met the trial entry criteria were randomised 1:1 to receive either everolimus 10mg once-daily or daily placebo orally, both in conjunction with BSC.