Afinitor Tablets Radiant-3 Phase III Study Met Primary Endpoint: Novartis Pharma

Everolimus is approved under the trade name Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

Novartis Pharma claimed that the study, Radiant-3 (RAD001 in Advanced Neuroendocrine Tumors), is part of the largest clinical trial program of its kind.

Radiant-3 is a Phase III prospective, double-blind, randomised, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care versus placebo plus best supportive care in 410 patients with advanced pancreatic NET, also known as islet cell tumors. Patients who met the study’s entry criteria were randomised 1:1 to receive either daily everolimus (10mg) or daily placebo orally.

Reportedly, the primary endpoint of Radiant-3 is progression-free survival. Secondary endpoints include safety, objective response rate and overall survival.

Full results from the Radiant-3 study is expected be submitted for presentation at the European Society for Medical Oncology annual meeting taking place in Milan, Italy in October. Additionally, worldwide regulatory filings are planned for 2010

Herve Hoppenot, president of Novartis Oncology, said: “Everolimus was developed to inhibit the mTOR protein, which is a critical target in treating various cancers, including NET. Results from Radiant-3 demonstrate that everolimus has the potential to become an important treatment option for patients with advanced pancreatic NET, where there is a major unmet need.

“These study results will serve as the basis of worldwide regulatory filings for everolimus and bring us one step closer to our goal of offering these patients a new therapy.”