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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
Non-small cell lung cancer tissue types3
ADENOCARCINOMA
SQUAMOUS-CELL
LARGE CELL
NOT SPECIFIED
38.5%
20.0%
2.9%
23.8%
85%3
NON-SMALLCELL LUNGCANCER
85%3
NON-SMALLCELL LUNGCANCER
14%314%3
1%OTHER
SMALL CELLLUNG CANCER
Patients with squamous NSCLC have a worse prognosis and limited
treatment options.4
Results from the Phase III LUX-Lung 5 trialshowed that afatinib* monotherapy demonstrated encouraging activity (median progression-free survival of 3.7 months) in treatment-refractory NSCLC patients with squamous-cell histology.5
LUX-Lung 8 Trial Design1
SECOND-LINE
PRIMARY ENDPOINT
Afatinib* Erlotinib
Progression Free Survival (PFS)
LUX-Lung 8 Head-to-head Trial Design2
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 randomisationOTHER 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 Criteria1
Diagnosis of advanced stage SCC of the lung
Completion of at least 4 cycles of platinum-based chemotherapy as
�rst-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 ef�cacy and safety of two EGFR-directed treatments, afatinib* and erlotinib in patients with advanced SCC of the lung
SCC of the Lung3,4,5,6
• 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 �ve 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 Results2
A higher proportion of patients treated with afatinib* reported an
improvement in overall well-being/quality of life2
% o
f pat
ient
s w
ho re
porte
d an
impr
ovem
ent
Overall Well-being / Quality of Life
All results are statistically signi�cant
28.3
Afatinib* Erlotinib
Median Progression-Free Survival
19% reduction in the risk of disease progression with
afatinib* versus erlotinib2
1.92.6M
ONTH
S
35.7
Median Overall Survival
19% reduction in the risk of death with
afatinib* versus erlotinib2
6.8
MON
THS 7.9