Phase III study of Tomtovok (Boehringer) meets endpoint for NSCLC

The LUX-Lung 6 randomized, open-label Phase III trial comparing Tomtovok (afatinib), from Boehringer, to standard chemotherapy in 364 Asian patients with Non Small Cell Lung Cancer has met its primary endpoint. Within the study population, patients treated with afatinib (n=242) lived for a median of 11.0 months before their tumor started to grow again versus 5.6 months for patients treated with chemotherapy (n=122). The PFS findings were consistent across EGFR mutation sub-groups. Patients treated with afatinib experienced significantly higher objective response rate (66.9% versus 23.0%) and disease control rate (92.6% versus 76.2%) compared to patients treated with chemotherapy. The most common adverse events observed with afatinib were rash/acne (14.6%), diarrhea (5.4%) and stomatitis/mucositis (5.4%).

Patient-reported outcomes were also evaluated as secondary endpoints: a higher proportion of afatinib patients reported 10 point or more improvements in cough (76% versus 55%), dyspnea (71% versus 48%) and pain (64% versus 47%). Results will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology.