Phase III data on Giotrif in NSCLC published in The Lancet Oncology-Boehringer

Boehringer announced overall survival (OS) results were published in The Lancet Oncology from two independent Phase III clinical trials (LUX-Lung 3 and LUX-Lung 6) in EGFR mutation-positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who were treated with Giotrif/Gilotrif (afatinib). In each trial, patients whose tumours have the most common EGFR mutation (deletion in exon 19; Del19) lived more than one year longer when treated with first-line afatinib compared to standard chemotherapy. Overall survival was a secondary endpoint. Afatinib is the first and only EGFR targeting agent to demonstrate an overall survival benefit compared to chemotherapy in the first-line treatment of NSCLC patients with EGFR mutations.

Results from both trials showed similar overall survival in the afatinib and chemotherapy arms in the overall NSCLC EGFR mutation-positive population (LUX-Lung 3: median OS 28.2 vs 28.2 months; LUX-Lung 6: median OS 23.1 vs 23.5 months), however, a significant benefit was observed in patients with the Del19 mutation. For these patients, both studies individually demonstrated a significant reduction in the risk of death with first-line afatinib compared to chemotherapy. That translated into a survival benefit of more than a year (LUX-Lung 3: median OS 33.3 vs 21.1 months; LUX-Lung 6: median OS 31.4 vs 18.4 months). The effect was not observed for patients with L858R mutations.