OSI has provided results from the phase III SATURN study on Tarceva (erlotinib). Tarceva 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.
Reportedly, overall survival was a key secondary endpoint of the study. The study showed that patients with NSCLC treated with Tarceva had a 23% improvement in overall survival, as compared to patients who received placebo.
The median survival 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, said the company.
Specific analysis of patients in the study, whose tumors were confirmed not to have genetic mutations in their epidermal growth factor receptor (EGFR), showed that this group experienced a 30% improvement in survival.
Gabe Leung, president of pharmaceutical business of OSI, said: 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.