A major Phase III trial of Novartis’ everolimus has been stopped early after interim results showed the agent was able to significantly boost the progression-free survival of patients with kidney cancer.

An independent data monitoring committee called an early halt to the RECORD-1 trial so that investigators could offer patients in the placebo group the chance to be treated with the drug after it demonstrated “highly-effective anti-tumour activity”, the group said.

Novartis chief Daniel Vasella claims the drug “has the potential to greatly help patients with kidney cancer, especially in advanced stage who up to now have had no treatment options”, and the company said it now plans regulatory filings on both sides of the Atlantic in the second half of the year.

Everolimus is a once-daily, oral therapy that represents a novel approach to treating cancer in that it inhibits the mTOR protein, which plays a key role in regulating tumour cell division and the growth of blood vessels in cancer cells. According to David Epstein, president and chief executive of Novartis Oncology, the progression-free survival benefit demonstrated in the trial highlights the potential of mTOR inhibition “as a promising target in oncology”.

The group is certainly hopeful that the drug, which is approved under the trade name Certican for the prevention of organ rejection, could offer a significant benefit to patients suffering from a number of different tumours and, to this end, is currently assessing its potential in a variety of different cancers, such as neuroendocrine tumours and lymphoma.

Full results of the RECORD-1 trial are due to be presented at the American Society of Clinical Oncology meeting in May.