Afatinib: Phase III data

The open-label, international Phase III LUX-Head & Neck 1 trial in 483 SCCHN patients who progressed after platinum-based treatment showed that once-daily 40 mg oral afatinib met the primary endpoint of improving median PFS vs. once-weekly IV methotrexate (2.6 vs. 1.7 months, p=0.03). Afatinib also met the secondary endpoint of improving DCR vs. methotrexate (49.1% vs. 38.5%, p=0.04), but missed the secondary endpoints of improving ORR (10.2% vs. 5.6%, p=0.1) and median OS (6.8 vs. 6 months) vs. methotrexate. Patients receiving afatinib also reported significantly less pain and a delay in time to worsening of symptoms, including pain, swallowing and global health status, vs. methotrexate. Data were presented at the European Society for Medical Oncology meeting in Madrid. ...