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let’s work LUX-LUNG 8 A randomised, open-label, phase III trial of afatinib* versus erlotinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung previously treated with first-line platinum-based chemotherapy 1. LUX-Lung 8 on clinicaltrials.gov 2. Soria JC et al. Afatinib (A) vs erlotinib (E) as second-line therapy of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following platinum-based chemotherapy: Overall survival (OS) analysis from the global phase III trial LUX-Lung 8 (LL8). Abstract #8002 at ASCO 2015 Annual Meeting. 3. Atlas of Genetics and Cytogenetics in Oncology and Haematology. Lung: Non-small cell carcinoma. Available at http://atlasgeneticsoncology.org/Tumors/LungNonSmallCellID5141.html. Accessed May 2015. 4. Bryant A, Cerfolio RJ. Differences in Epidemiology, Histology, and Survival Between Cigarette Smokers and Never-Smokers Who Develop Non-small Cell Lung Cancer. Chest 2007;132:185–192. 5. Cancer Monthly. Lung Cancer (NSCLC). Available at: http://www.cancermonthly.com/cancer_basics/lung.asp. Accessed May 2015. 6. Cetin K et al. Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139–148. © Boehringer Ingelheim International GmbH. All rights reserved | Last updated: May 2015. *Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF ® and in the US under the brand name GILOTRIF ® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib* is under regulatory review by health authorities in other countries worldwide. Afatinib* is not approved in SCC or other indications. FOR JOURNALISTS OUTSIDE THE US/UK/CANADA ONLY LUX-Lung 8 Head-to-head Trial Design 2 PRIMARY ENDPOINT: Progression-Free Survival (PFS: length of time before the tumour starts to progress) after randomisation KEY SECONDARY ENDPOINT: Overall Survival (OS: length of time a patient has survived) after randomisation OTHER ENDPOINTS: Objective Response (ORR), Disease Control (DCR), Patient Reported Outcomes and Safety Patients with advanced SCC whose disease has progressed following at least 4 cycles of platinum-based chemotherapy Afatinib* (irreversible ErbB Family Blocker) Erlotinib (EGFR tyrosine kinase inhibitor (TKI)) 1 1 RANDOMISED Inclusion Criteria 1 Diagnosis of advanced stage SCC of the lung Completion of at least 4 cycles of platinum-based chemotherapy as first-line treatment of Stage IIIB/IV NSCLC Eligible to receive second-line therapy in the opinion of the investigator LUX-Lung 8 directly compared the efficacy and safety of two EGFR-directed treatments, afatinib* and erlotinib in patients with advanced SCC of the lung SCC of the Lung 3,4,5,6 • Develops in the cells lining the airway • Represents approximately 30% of non-small cell lung cancer (NSCLC) cases • Treatment options are limited • SCC of the lung is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer The rate of severe adverse events was similar between afatinib* and erlotinib treatment arms (57.1 versus 57.5%). A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib* compared to erlotinib (grade 3/4 diarrhoea: 9.9/0.5 versus 2.3/0.3%, grade 3 stomatitis: 4.1 versus 0.0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib* (grade 3 rash/acne: 10.4 versus 5.9%). Safety profile LUX-Lung 8 Results 2 A higher proportion of patients treated with afatinib* reported an improvement in overall well-being/quality of life 2 % of patients who reported an improvement Overall Well-being / Quality of Life All results are statistically significant 28.3 Afatinib* Erlotinib Median Progression-Free Survival 19% reduction in the risk of disease progression with afatinib* versus erlotinib 2 1.9 2.6 MONTHS 35.7 Median Overall Survival 19% reduction in the risk of death with afatinib* versus erlotinib 2 6.8 MONTHS 7.9
