Novartis Presents Positive Data - Analyst Blog

Novartis (NVS) provided encouraging data on Afinitor (everolimus) from a Phase III trial conducted in patients with advanced pancreatic neuroendocrine tumors (NET). It was observed that the combination of Afinitor and best supportive care met the primary endpoint by extending the time period without tumor growth. Novartis plans to submit the regulatory filing for the drug later this year. Afinitor is also being studied in many cancer types including breast cancer, lymphoma, tuberous sclerosis complex (TSC) and gastric cancer.

 

The RADIANT-3 study, conducted on 410 patients, was aimed at evaluating the efficacy and safety of everolimus plus best supportive care compared to placebo and best supportive care. Patients were randomized to receive either everolimus in dosage of 10 mg daily or placebo orally. While progression-free survival was the primary endpoint, secondary endpoints included safety, objective response rate and overall survival.

 

Everolimus is currently approved under the trade name Afinitor in the EU for the treatment of patients with advanced renal cell carcinoma (RCC), which has progressed after being treated with vascular endothelial growth factor-targeted therapy. In the US, Afinitor is approved for those RCC patients who have failed treatment with Pfizer’s (PFE) Sutent (sunitinib) or Bayer’s (BAYRY) Nexavar (sorafenib).

 

Additionally, everolimus is available under the trade name Certican in the EU for the prevention of organ rejection in heart and kidney transplant recipients. In the US, the drug sells under the trade name Zortress for the prevention of rejection in kidney transplant patients.

 

Oncology was the largest franchise in the Pharmaceuticals segment of Novartis with $9 billion in sales in 2009, a growth of 14% over 2008. Products with robust growth in this area were Glivec ($3.9 billion, up 12%), Zometa ($1.5 billion, up 9%), Femara ($1.3 billion, up16%) and Sandostatin ($1.2 billion, up 7%). Afinitor, approved in 2009, recorded $70 million in sales.

 

Label expansion of Afinitor beyond RCC will enable the drug to generate higher sales in the future.