Giotrif meets endpoints in Phase III trial for Head & Neck Cancer - Boehringer

Boehringer announced Phase III data from the LUX-Head & Neck 1 study evaluating the efficacy and safety of Giotrif / Gilotrif (afatinib) in patients with recurrent and/or metastatic Head & Neck squamous cell Cancer versus methotrexate. The results of this global trial, with 483 patients from 19 countries, showed that afatinib, a once-daily, irreversible ErbB blocker, is the first tyrosine kinase inhibitor to significantly delay tumour growth versus chemotherapy in patients with head and neck squamous cell cancer after failure of previous therapy. LUX-Head & Neck 1 met its primary endpoint of progression-free survival by showing that patients taking afatinib, after failure of previous platinum-based chemotherapy, experienced a significant delay in tumour growth of 2.6 months versus 1.7 months with chemotherapy. This translated into a 20% reduction in risk of disease progression.

With regard to secondary endpoints, afatinib significantly improved the disease control rate (DCR: the percentage of patients whose tumour size was stable or reduced, 49.1% vs. 38.5%), and the objective response rate was numerically higher with afatinib compared to chemotherapy (10.2% vs. 5.6%). No significant difference between afatinib and chemotherapy was observed regarding overall survival (median 6.8 vs. 6.0 months). Results will be presented at the European Society for Medical Oncology 2014 Congress.