Gilotrif afatinib: Additional Phase IIb data

Additional data from the open-label, international Phase IIb LUX-Lung 7 trial in 319 treatment-naive patients with EGFR mutation-positive NSCLC showed that first-line treatment with once-daily 40 mg afatinib missed the co-primary endpoint of improving median OS vs. once-daily 250 mg Iressa gefitinib (27.9 vs. 24.5 months, HR=0.86, 95% CI: 0.66, 1.12, p=0.258). Afatinib met the co-primary endpoints of improving median PFS (11 vs. 10.9 months, HR=0.73, 95% CI: 0.57, 0.95, p=0.017) and median time to treatment failure (13.7 vs. 11.5 months, HR=0.73, 95% CI: 0.58, 0.92, p=0.0073) vs. Iressa. Afatinib also met the secondary endpoint of improving ORR vs. Iressa (70% vs. 56%, p=0.0083). Additionally, afatinib led to a 2-year PFS rate of 18% vs. 8% for Iressa. Data were presented at the European Society for Medical Oncology meeting in Copenhagen. Boehringer previously reported data from the trial (see BioCentury, Jan. 4). ...