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

Novartis International AG / Novartis drug Afinitor is first treatment for advanced pancreatic NET to provide overall survival of more than 3.5 years in Phase III trial . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Afinitor led to an unprecedented median overall survival of 44 months, which represents a clinically meaningful while not statistically significant improvement[1]
   

Pancreatic NET (pNET) affects about 2.2 per 1 million people worldwide annually; the advanced form is aggressive and has limited treatment options[2],[3]
 

Results affirm the role of mTOR (mammalian target of rapamycin) inhibition in advanced pNET; data to be submitted to health authorities[1],[4]

Basel, September 27, 2014 - Novartis today presented final results on overall survival (OS) 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 tumors (pNET)[1]. Overall survival was a secondary endpoint of the trial[1]. The findings were presented at the European Society for Medical Oncology (ESMO) Congress, September 26-30, 2014 in Madrid, Spain, and are to be submitted to health authorities for inclusion in the Afinitor prescribing information.

Results from the RADIANT-3 trial showed a median OS of 44.02 months (95% confidence interval [CI]: 35.61, 51.75) in the everolimus treatment arm and 37.68 months (95% CI: 29.14, 45.77) in the placebo arm[1]. The 6.34 month difference between the two arms was not statistically significant (Hazard Ratio [HR] 0.94; 95% CI: 0.73, 1.20; p=0.300) [1]. A high crossover of patients from placebo to everolimus (85%) likely contributed to the long median OS in the placebo arm of 37.68 months and may have confounded the ability to detect a difference in the OS results[1].

"The median overall survival of 44 months for everolimus is unprecedented in controlled clinical trials for advanced progressive pancreatic neuroendocrine tumors," said James Yao*, MD, lead investigator, The University of Texas MD Anderson Cancer Center, Houston, Texas. "The results affirm the importance of targeting key pathways involved in tumor growth, such as the mTOR pathway in advanced pNET."

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[1]. The most commonly reported (>=40%) adverse events (AEs) for everolimus compared to placebo during the core phase of the study were stomatitis (53.9% vs. 13.3%), rash (52.5% vs. 15.8%), diarrhea (48.0% vs. 23.6%) and fatigue (44.6% vs. 26.6%)[1]. The most common (>=40%) AEs reported with everolimus during this follow-up phase were stomatitis (46.7%), diarrhea (43.6%) and rash (40.0%)[1].