New Data from Phase III SATURN Study Showed Tarceva Extended Survival in Patients with Advanced Non-Small Cell Lung Cancer Wh...

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced further results from the Phase III SATURN study showing that Tarceva® (erlotinib) extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy. As previously announced, the safety results in this study were consistent with what has been seen previously and there were no new or unexpected safety signals. Overall survival was a key secondary endpoint of the study and these new data were presented today at the 13th World Conference on Lung Cancer being held in San Francisco.

“Based on the data presented today, Tarceva is the first oral cancer therapy to show a survival benefit in the first-line maintenance NSCLC setting. Assuming approval, when used immediately after chemotherapy, Tarceva will provide a new, convenient, non-chemotherapy treatment option for patients - allowing doctors to continue treating a patient’s disease without exposing them to the continuous burden and lifestyle constraints of long-term chemotherapy," stated Gabe Leung, President, Pharmaceutical Business of OSI Pharmaceuticals.

The study showed that patients with NSCLC treated with Tarceva had a 23 percent improvement in overall survival compared with patients who received placebo (hazard ratio=0.81; p-value=0.0088). The hazard ratio, which assesses risk in the overall trial population, is widely recognized as the best measure of overall benefit in large randomized clinical trials. A hazard ratio of less than one for survival indicates a reduced risk of death. The median survival (a single point estimate of benefit) for patients receiving Tarceva was 12 months versus a median survival of 11 months for patients receiving placebo.

The study confirmed that a broad spectrum of patients with advanced NSCLC experienced a survival benefit from Tarceva. Specific analysis of patients in the study whose tumors were confirmed not to have genetic mutations in their epidermal growth factor receptor (EGFR “wild-type”) showed that this group experienced a 30 percent improvement in survival (hazard ratio = 0.77; p-value = 0.0243). The majority of patients with NSCLC are EGFR wild-type. Full data analysis for various sub-groups is still on-going. However, available data also showed that the hazard ratio for overall survival in patients with tumors expressing the EGFR gene by Immunohistochemistry (IHC) was also 0.77 (p-value = 0.0063).

As presented previously, the hazard ratio for progression-free survival (the time patients live without their disease worsening) in patients with EGFR mutations was 0.10 (p-value