New data from phase III trial of Giotrif/Gilotrif (afatinib) in squamous cell carcinoma of the lung- Boehringer Ingelheim

At the European Cancer Congress (ECC) in Vienna, Boehringer Ingelheim announced new data from the Phase III LUX-Lung 8 trial which further highlights the benefits of Giotrif/Gilotrif (afatinib) compared to Tarceva (erlotinib) for the treatment of patients with previously-treated advanced squamous cell carcinoma (SCC) of the lung. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS) and superior overall survival (OS) compared to erlotinib in this patient population. These improved survival outcomes observed with afatinib were not driven by the presence of EGFR mutations, according to a new analysis presented at ECC.

Data from the trial showed that treatment with afatinib resulted in superior PFS, reducing the risk of cancer progression by 19%, and superior OS, reducing the risk of death by 19% compared to erlotinib in this patient population. More patients had improved overall health-related quality of life (36% vs 28%, p=0.041), cough (43% vs 35%, p=0.029) and dyspnoea (51% vs 44%, p=0.061) with afatinib than with erlotinib. The rate of severe adverse events in the LUX-Lung 8 trial was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 10% vs 2%; grade 3 stomatitis: 4% vs 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs 6%). Diarrhoea occurring in patients treated with afatinib was described as manageable.

Comment: afatinib was approved for NSCLC in the US and EU in 2013. Erlotinib is its most serious competitor, approved for first line metaststic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and a diagnostic test. By 2013 Tarceva had captured most of the US EGFR inhibitor market. On available data, afatinib is also associated with more side effects.