Novartis’ Afinitor advances in trials

Novartis has announced plans to initiate a phase III trial of Afinitor.

Set to be undertaken in HER-2-positive metastatic breast cancer patients, the company said its decision was due to positive results in two other tests.

The research found Afinitor – in combination with paclitaxel and Herceptin – had a disease response rate (DRR) of 77 per cent, with the second of the studies noting the drug, when combined with vinorelbine and Herceptin resulted in a DRR of 62 per cent.

An orally available analog of the mammalian target of rapamycin (mTOR), the drug is already approved in a number of countries, under the brand name of Certican.

It is used in combination with cyclosporine for the prevention of rejection episodes following organ transplantation.

Afinitor is additionally in phase III clinical trials for neuroendocrine tumours, colorectal cancer, carcinoid tumours and gastrointestinal stromal tumours, as well as HER-2-negative breast cancer.

The drug is currently in pre-registration in Western Europe and the US and its first oncology indication is likely to be renal cell carcinoma.

Based in Basel, Switzerland, Novartis currently employs 100,000 people and operates in 140 countries.

It increased research and development investments by more than 20 per cent to $6.4 billion (4.26 billion pounds) over 2007.