Data from the LUX-Lung 8 trial demonstrated that afatinib significantly delayed disease progression (primary endpoint) and prolonged overall survival (key secondary endpoint) in patients with squamous cell carcinoma of the lung (SCC) compared to erlotinib. Afatinib was found to improve patient survival outcomes compared to erlotinib independent of tumor EGFR mutation status, suggesting that afatinib is a broadly applicable treatment for squamous cell carcinoma of the lung. Further data published in ECC 2015 confirmed that the efficacy of afatinib observed in the LUX-Lung 8 trial was also associated with improved patient-reported outcomes.3 Both the FDA and EMA have accepted applications for “afatinib for the treatment of patients with advanced squamous cell carcinoma of the lung”. Boehringer Ingelheim announced at the European Cancer Congress (Vienna, Austria) that new Phase III clinical data from the LUX-Lung 8 trial further highlight the benefit of afatinib compared to erlotinib in patients with treated squamous cell carcinoma of the lung. Data from the trial suggest that progression-free survival (PFS) and overall survival (OS) were better in this patient population when treated with afatinib than when receiving erlotinib.2 According to a new analysis presented at the ECC, the improvement in survival outcomes observed in patients treated with afatinib was not affected by EGFR mutation status.2 Thus, in the LUX-Lung 8 trial, compared to more patients treated with afatinib reported improvements in overall health and quality of survival, as well as improvements in some lung cancer-related symptoms, compared to patients treated with erlotinib.3 Glen D. Goss, MD, PhD, investigator of the LUX-Lung 8 trial and director of clinical and translational research at the University of Ottawa Cancer Centre, Ottawa Hospital, Ottawa, Canada, commented. “These recent data not only demonstrate the benefit that afatinib brings to patients with lung squamous cell carcinoma compared to erlotinib, but also suggest that afatinib is a broadly effective treatment option that is not limited to patients with the presence of EGFR mutations. We know that abnormal ErbB receptor regulation plays a role in the underlying mechanism of lung squamous cell carcinoma, and the fact that afatinib targets the entire ErbB receptor family, not just EGFR, may provide additional benefit to this patient population. Afatinib is an orally targeted drug administered once daily that works by irreversibly blocking the ErbB family of receptors. Unlike other targeted therapies (such as erlotinib, which is reversible and targets EGFR (ErbB1) exclusively), afatinib provides sustained, selective blockade of the entire ErbB receptor family. the LUX-Lung 8 phase III trial compared afatinib to erlotinib in patients with advanced squamous cell carcinoma of the lung who had progressed after first-line chemotherapy with platinum-containing agents. Data from the trial showed that in this patient population, afatinib treatment had better PFS and a 19% lower risk of cancer progression compared to erlotinib treatment, and that afatinib treatment had better OS and a 19% lower risk of patient death.1,2 Analysis revealed that the PFS and OS advantage observed in the afatinib arm of the trial over erlotinib was not affected by EGFR mutation status. Further data published by the ECC confirmed that the efficacy of afatinib observed in the LUX-Lung 8 trial was also associated with improvements in patient-reported outcomes.3 Compared to the erlotinib-treated group, the afatinib-treated group had more patients with overall health-related quality of survival (36% vs. 28%, p=0.041), cough (43% vs. 35%, p=0.029) and Respiratory distress (51% vs 44%, p=0.061) improved.3 In the LUX-Lung 8 trial, the incidence of serious adverse events was similar in both treatment groups, while the incidence of certain side effects differed.1 The incidence of severe diarrhea and stomatitis (mouth ulcers) was higher in the afatinib group compared with the erlotinib group (grade 3 diarrhea: 10% vs 2%; grade 3 stomatitis The incidence of severe rash/acne reported in the erlotinib group was higher than in the afatinib group (grade 3 rash/acne: 10% vs. 6%).1 Diarrhea in patients treated with afatinib is manageable.3 Dr. Mehdi Shahidi, medical director of solid tumors at Boehringer Ingelheim, commented, “We are very pleased with the results of this year’s European Cancer Congress. We are pleased to present these data at this year’s European Cancer Congress (ECC), confirming that the advantage of afatinib over erlotinib is universal and not limited to patients with rare squamous cell carcinoma of the lung expressing EGFR mutations. the LUX-Lung 8 trial demonstrated that compared to erlotinib treatment, afatinib treatment not only improves patient survival outcomes, but also improves patient quality of survival. “The application for afatinib for the treatment of squamous cell carcinoma of the lung is under review by the FDA and EMA, and we look forward to working with the regulatory agencies to bring this highly anticipated new drug to market soon for the benefit of patients.” Afatinib is currently approved in more than 60 countries for the first-line treatment of certain types of EGFR mutation-positive non-small cell lung cancer (NSCLC) (trade name GIOTRIF? / GILOTRIF?). Based on positive PFS and OS data from the LUX-Lung 8 trial, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently accepted the application for afatinib for the treatment of patients with advanced squamous cell lung cancer that has progressed after first-line chemotherapy. Afatinib has also been granted orphan drug status by the FDA – for the treatment of rare diseases.