Afatinib: Phase III data

The open-label, international Phase III LUX-Lung 8 trial in 795 patients with stage IIIB/IV SCC of the lung who progressed after >=4 cycles of platinum-based doublet chemotherapy showed that once-daily 40 mg oral afatinib met the primary endpoint of improving median PFS vs. Tarceva erlotinib (2.4 vs. 1.9 months, p=0.043). Afatinib also met the secondary endpoint of improving DCR vs. Tarceva (45.7% vs. 36.8%, p=0.02), but missed the secondary endpoint of improving ORR vs. Tarceva (4.8% vs. 3%, p=0.233). Data for the secondary endpoint of OS data are not yet mature. Data were presented at the European Society for Medical Oncology meeting in Madrid. ...