Gilotrif afatinib: Phase IIb data

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 led to a median PFS of 11 months vs. 10.9 months for once-daily 250 mg Iressa gefitinib (HR=0.73). Afatinib led to 18- and 24-month PFS rates of 27% and 18%, respectively, vs. 15% and 8% for Iressa. The median time to treatment failure was 13.7 months for afatinib vs. 11.5 months for Iressa. Additionally, afatinib led to an ORR of 70% vs. 56% for Iressa. The median duration of response was 10.1 months for afatinib vs. 8.4 months for Iressa. OS data are not yet mature at a median follow-up of 27.3 months. Data were presented at the ESMO Asia 2015 meeting in Singapore. ...