Afatinib: Phase IIb/III data
The double-blind, international Phase IIb/III LUX-Lung 1 trial in >580 patients with advanced NSCLC who had previously received chemotherapy and either Tarceva erlotinib or Iressa gefitinib showed that afatinib plus best supportive care (BSC) missed the primary endpoint of significantly improving OS vs. placebo plus BSC (10.78 vs. 11.96 months, p=0.7428). Afatinib did meet the secondary endpoint of significantly improving PFS vs. placebo (3.3 vs. 1.1 months, p<0.0001). Afatinib also led to a significantly higher disease control rate at week 8 vs. placebo (58% vs. 19%, p<0.0001). Additionally, afatinib improved lung-cancer related symptoms of cough, dyspnea and pain vs. placebo, and delayed the time to deterioration of cough, individual dyspnea items and chest pain. The most common afatinib-related side effects were diarrhea and rash/acne. Data were presented at the European Society for Medical Oncology meeting in Milan. ...