Last week, Tarceva became the first EGF receptor inhibitor to show a survival benefit in a single, controlled trial. Assuming that Tarceva is approved, this could give OSI Pharmaceuticals Inc. and partners Genentech Inc. and Roche a leg up on the competition in the near term. But the EGFr inhibitor landscape is far from complete, and there are multiple ongoing trials where survival is the primary endpoint.
In the top-line results of the Phase III BR21 trial in non-small cell lung cancer (NSCLC), announced last week, 150 mg/day of Tarceva erlotinib improved overall survival compared to placebo, the primary endpoint, in 731 patients with recurrent stage IIIB/IV NSCLC who had received one or two prior chemotherapy regimens. The compound also improved the secondary endpoints of time to symptomatic deterioration, progression-free survival and response rate.