Positive Phase III results for Gilotrif in SCC - Boehringer

Phase III data from Boehringer�s LUX-Lung 8 trial, the first study to directly compare the efficacy of two different targeted agents in patients with advanced Squamous Cell Carcinoma (SCC) of the lung, demonstrated superior progression-free survival (PFS) of Gilotrif/Giotrif (afatinib) compared to erlotinib. SCC represents approximately 30% of NSCLC cases. Afatinib showed significant improvement across several measures of efficacy, in particular for the primary endpoint of PFS compared to erlotinib in patients after failure of first-line chemotherapy. LUX-Lung 8 demonstrated that afatinib significantly reduced the risk of disease progression by 18% when compared to erlotinib, and delayed tumour growth (PFS by independent review: 2.4 vs. 1.9 months).

In addition, afatinib showed an improvement in the secondary endpoint of disease control rate (DCR: the percentage of patients who achieved complete response, partial response or stable disease, 46% vs. 37%). The objective response rate (ORR) was numerically higher with afatinib compared to erlotinib (5% vs. 3%). The overall rate of severe (more than grade 3) and serious adverse events was comparable between both therapies. Incidence of severe adverse events (more than grade 3) was 50.2% in patients treated with afatinib compared to 49.1% with erlotinib. The results are being presented at the European Society for Medical Oncology (ESMO) 2014 Congress.