Data released by Novartis show Afinitor (also known as RAD001, everolimus) halted tumour growth in 55 per cent of patients with advanced gastric cancer, a condition for which there are limited treatment options. In addition, 45 per cent of patients in the study demonstrated some tumour shrinkage.
The open label, single arm, multi-centre phase-II study of 54 patients conducted in Japan, is designed to assess the efficacy and safety of Afinitor in patients with advanced gastric cancer whose disease progressed despite prior treatment. Patients enrolled in the trial were heavily pre-treated. All trial participants were from Japan and of Asian descent.
"There are very limited treatment options for patients who progressed despite the standard treatment for this aggressive cancer," said Atsushi Ohtsu, director, Research Center for Innovative Oncology, National Cancer Center Hospital East, China, Japan. "The results from this study demonstrate that Afinitor has the potential to provide an effective new option for these patients."
A global phase-III clinical trial program to evaluate the efficacy and safety of Afinitor monotherapy in approximately 500 advanced gastric cancer patients will begin enrolment this year.
"Most advanced gastric cancer patients eventually stop responding to current therapies, demonstrating a considerable need for new treatment options," said Alessandro Riva, executive vice president & global head of Development, Novartis Oncology. "Early data show Afinitor may benefit these patients and provides the rationale for additional studies. Novartis is committed to further exploring the potential of Afinitor for this hard-to-treat cancer, as well as studying its role in treating other tumour types."
Gastric cancer, commonly referred to as stomach cancer, is responsible for more than 865,000 deaths each year, making it the second leading cause of cancer death worldwide. This cancer is highly prevalent among people of Asian descent, with more than half of all new cases occurring in East Asia. It is believed that the incidence is high among this population due in part to Helicobacter pylori infection and a diet high in smoked, salted or pickled foods.
Afinitor, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumour types. In cancer cells, Afinitor provides daily inhibition of mTOR, a protein that acts as a central regulator of tumour cell division, cell metabolism and blood vessel growth.