RAD001 Generates Promising Results in Gastric Cancer Trial 1/28/2009

RAD001 halted tumor growth in more than half of advanced gastric cancer patients enrolled in a phase 2 clinical trial.

RAD001’s active ingredient is everolimus, an oral inhibitor of mTOR, or the mammalian target of rapamycine serine-threonine kinase. mTOR regulates cell growth, cell proliferation, and angiogenesis.

The open-label, single-arm study included 54 advanced gastric cancer patients of Asian descent who were previously treated with chemotherapy. (Gastric cancer is most highly prevalent among people of Asian descent.)

After eight weeks of daily treatment with 10 mg of RAD001, tumor growth stopped in 55% of the patients and tumor shrinkage occurred in 45%. The median progression-free survival was 83 days, and approximately 30% of patients were still progression-free at four months.

Novartis will initiate a phase 3 clinical trial of RAD001 that will enroll about 500 advanced gastric cancer patients. The drug is also being studied for the treatment of other types of cancer.

These findings were presented at the American Society of Clinical Oncology’s 2009 Gastrointestinal Cancers Symposium.