Genentech and OSI Pharmaceuticals today announced that a global phase III study of Tarceva--dubbed Saturn--met the primary endpoint of progression-free survival. The study, conducted by Roche, enrolled 889 patients with advanced non-small cell lung cancer (NSCLC). When compared with the placebo, Tarceva significantly extended the time patients lived without their cancer getting worse when given immediately following initial treatment of chemotherapy.
Tarceva is currently approved as a second-line treatment for patients with advanced NSCLC, who have progressed following treatment with at least one prior chemotherapy regimen. OSI, Genentech and Roche will discuss next steps for a potential new indication for Tarceva with the FDA and European Health Authorities, according to the joint statement.
"There is an unmet need for treatments that can be used as early as possible following initial treatment of NSCLC and the results from the SATURN study provide a strong rationale for introducing Tarceva as a maintenance therapy in this difficult to treat disease," said Professor F. Capuzzo, M.D., lead investigator of the study.
- check out the joint release for more