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Patient populations by geography

Asian patients in LUX-Lung 3 and 7

Data from LUX-Lung 3 (72% Asian population) and LUX-Lung 7 (57% Asian population) indicate that efficacy of afatinib* in Asian patients with non-small cell lung cancer (NSCLC) is in line with that seen in other study populations, with epidermal growth factor receptor (EGFR) mutation status being a key predictor of efficacy, rather than ethnicity.1,2 For instance, the hazard ratio (HR) for progression-free survival (PFS) in LUX-Lung 7 was 0.72 for non-Asian patients and 0.76 for the Asian population.2

Japanese patients in LUX-Lung 3

A subgroup analysis of Japanese patients who participated in LUX-Lung 3 showed a significant increase in PFS with afatinib compared with cisplatin/pemetrexed in all Japanese patients, as well as in patients with common EGFR mutations. Overall survival (OS) was significantly longer with afatinib than with chemotherapy in patients with del19 mutations (46.9 vs 31.5 months), but did not differ significantly between treatment arms in patients with L858R mutations.3

PFS outcomes for Japanese patients in LUX-Lung 3

PFS in Japanese patients; afatinib vs cis/pem

CI, confidence interval; Cis, cisplatin; HR, hazard ratio; Pem, pemetrexed; PFS, progression-free survival.

OS outcomes for Japanese patients with del19 mutations in LUX-Lung 3

Figure for OS in Japanese patients with del19/L858R mutations; afatinib vs cis/pem

CI, confidence interval; Cis, cisplatin; HR, hazard ratio; Pem, pemetrexed; OS, overall survival.

Chinese patients in LUX-Lung 6

The LUX-Lung 6 Phase III trial was conducted in Asian countries with 90% of randomised patients being Chinese. A post-hoc analysis of the Chinese patient subset demonstrated that afatinib significantly increased PFS compared with gemcitabine/cisplatin in all patients (median 11.0 vs 5.6 months) and in patients with EGFR Del19 or L858R mutations (median 11.0 vs 5.6 months).4 An increase in OS was also observed versus gemcitabine/cisplatin in patients with EGFR Del19 mutations (median 31.6 vs 16.3 months).4 There were no unexpected safety findings with afatinib in Chinese patients.4

Chinese patients with squamous NSCLC in LUX-Lung 8

A post-hoc subgroup analysis of data from 67 Chinese patients with advanced squamous NSCLC in LUX-Lung 8 confirmed that the efficacy, safety and tolerability of afatinib in this subgroup are in line with that seen in the overall study population.5 Trends favouring afatinib versus erlotinib in terms of PFS (HR=0.70; 95% CI: 0.38–1.27), OS (HR=0.69; 95% CI: 0.39–1.21), tumour control and improvements in patient-reported outcomes (PRO) were comparable to those in the overall study population.5

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Mok T, et al. J Thorac Oncol 2012;7(11, Suppl. 5):Abstract HO-003.


Park K, et al. Lancet Oncol 2016;17(5):577–89.


Kato T, et al. Cancer Sci 2015;106(9):1202–11.


Xu C-R, et al. Poster presented at CSCO 2017 (Poster P-19).


Lu S, et al. Poster presented at CSCO 2017 (Poster P-18).

*Afatinib is approved in more than 80 markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list, please click here. Registration conditions differ internationally; please refer to locally approved prescribing information.


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Last updated: October 2018