晚期NSCLC靶向治疗,,研究生课剖析.ppt

* * ARMS，29种突变 * * * * The timelines for three key Phase III trials with IRESSA in NSCLC are shown here: ISEL1, INTEREST2 and IPASS3,4; INTEREST and IPASS were the two pivotal studies for the EU submission. IRESSA was first registered for NSCLC in 2002 but the significance of biomarkers and in particular EGFR mutations was discovered relatively late in its development. Early in development it was possible to show that there was complete inhibition of EGFR receptor signalling by the drug. Following the results from ISEL, a trial in a very refractory patient population, it became clear that it