MetMAb: Preliminary Phase II data

Preliminary data from the double-blind, international Phase II OAM4558g trial in 128 patients showed that 15 mg/kg IV MetMAb every 3 weeks plus Tarceva erlotinib improved median PFS, the primary endpoint, vs. placebo plus Tarceva in patients with high c-MET-expressing NSCLC (12.4 vs. 6.4 weeks, p=0.0547). Roche's Genentech unit said the data are "clinically meaningful." MetMab plus Tarceva also improved OS vs. placebo plus Tarceva in patients with high c-MET expression (7.7 vs. 7.4 months, p=0.1113). In patients with low c-MET-expressing NSCLC, MetMAb plus Tarceva led to worse PFS and OS vs. placebo plus Tarceva (p=0.0354 and p=0.0142, respectively). MetMab plus Tarceva was well tolerated with no unexpected safety signals observed. Patients were stratified according to c-Met receptor expression in their tumor sample using an immunohistochemistry assay developed in collaboration with Roche's Ventana Medical Systems Inc. unit. Data were presented at the European Society for Medical Oncology meeting in Milan. ...