Novartis Posts Positive Phase 3 Data For Afinitor In pNET

Novartis reported positive final results from a Phase 3 trial investigating Afinitor (everolimus) tablets versus placebo in patients with pancreatic neuroendocrine tumors (pNET).

Afinitor is currently approved in the U.S. and EU as well as in over 85 countries for the treatment of neuroendocrine tumors of pancreatic origin and renal cell carcinoma, among other indications.

The Phase 3 RADIANT-3 trial investigated Afinitor plus best supportive care (BSC) against placebo plus BSC in patients with distinct advanced and progressive pNET. The drug achieved a median overall survival (OS) of 33 months or over 3.5 years, indicating a clinically meaningful but not statistically significant improvement. OS was a secondary endpoint in the study. Novartis noted that the high crossover of patients from the placebo arm to Afinitor might have contributed to the long median OS in the placebo arm (37.68 months) and may have affected the accuracy of detecting a difference in the patients’ OS.

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

Alessandro Riva, Global Head of Novartis Oncology Development and Medical Affairs, said, “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.”

Earlier this year, Afinitor also extended survival in a Phase 3 trial in HR+/HER2- advanced breast cancer. The drug plus exemestane was able to more than double the progression-free survival of patients involved in the trial, supporting its applications and approval in different countries around the world.

The company presented the analysis of the mature OS results at the European Society for Medical Oncology (ESMO) Congress this month in Madrid, Spain. Novartis said it will submit the additional study findings to regulatory authorities to be included in the drug’s prescribing information.