TARCEVA STUDY SHOWS LUNG-CANCER SURVIVAL IMPROVEMENT

OSI Pharmaceuticals and Genentech announced that The New England Journal of Medicine published results from the pivotal Phase III study showing Tarceva improved survival in patients with advanced non-small cell lung cancer (NSCLC).

The FDA approved Tarceva in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

In addition to showing that Tarceva improved survival in advanced lung cancer, the trial indicated the drug extended survival across most subsets of patient populations in the trial. The global study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University.

The Tarceva results are from a randomized double-blind, placebo-controlled trial of patients with second and third-line relapsed or refractory NSCLC. Patients who received Tarceva had a 30 percent reduction in the risk of death compared with patients who received placebo. In addition, 31 percent of Tarceva-treated patients were alive at one year, versus 22 percent of those treated with the placebo.