Erbitux cetuximab: Additional Phase III data

Data from 342 mCRC patients with wild-type K-Ras and neuroblastoma Ras viral (v-Ras) oncogene (NRAS) exons 2, 3 and 4 in the open-label, German Phase III FIRE-3 trial showed that first-line treatment with Erbitux plus FOLFIRI chemotherapy significantly improved median OS vs. Avastin bevacizumab plus FOLFIRI chemotherapy (33.1 vs. 25.6 months, p=0.011). Erbitux plus FOLFIRI led to an ORR of 65.5% vs. 59.6% for Avastin plus FOLFIRI (p=0.157), while median PFS in the subgroup was 10.4 months in the Erbitux arm vs. 10.2 months in the Avastin arm (p=0.54). A post hoc analysis of mCRC patients with any Ras mutation (n=178) showed that Erbitux plus FOLFIRI led to a median OS of 20.3 months vs. 20.6 months for Avastin plus FOLFIRI (p=0.6). Erbitux plus FOLFIRI led to an ORR of 38% vs. 51.2% for Avastin plus FOLFIRI (p=0.097), while median PFS in the subgroup was 7.5 months in the Erbitux arm vs. 10.1 months in the Avastin arm (p=0.085). The trial was sponsored by the University of Munich. Data were presented at the European Cancer Congress in Amsterdam. ...