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INGELHEIM, Germany – Data from two pivotal large-scale Phase III registration studies, LUX-Lung 3 and LUX-Lung 6, showed superior efficacy and a manageable safety profile in both Asian and non-Asian lung cancer patients compared to chemotherapy.2,3 A new analysis of the trials has substantiated the consistent safety profile of afatinib as a first-line treatment in Asian and non-Asian patients with EGFR mutation positive non-small cell lung cancer (NSCLC).1
The efficacy of afatinib is further reinforced by new data in NSCLC patient subpopulations. Additional analyses from the LUX-Lung trials demonstrate the efficacy of afatinib in NSCLC patients with uncommon EGFR mutations4and those with metastatic brain disease.5
The findings, presented at this year’s World Conference on Lung Cancer (WCLC), add to a growing body of robust clinical evidence which supports the first-line use of afatinib in Asian and non-Asian patients with a distinct type of advanced lung cancer, known as Epidermal Growth Factor Receptor (EGFR) mutation positive NSCLC.
The global trial LUX-Lung 3 and its companion trial LUX-Lung 6, which was conducted in China, Korea and Thailand, together represent the two largest clinical registration trials conducted to date in patients with EGFR mutation positive NSCLC. The trials have already shown patients treated with afatinib lived for almost a year before their tumour started to grow again (progression-free survival [PFS]) versus just over half a year for those on chemotherapy. Specifically, the trials demonstrated: 2,3
In LUX-Lung 6, 47% of afatinib-treated patients were alive and progression-free after 1 year of treatment compared to only 2% on chemotherapy.3 The delay in tumour progression was coupled with improvements in patients’ lung cancer related symptoms (e.g. shortness of breath, cough and chest pain) and quality of life as assessed by standard lung cancer questionnaires.2,3
In Asia, lung cancer accounts for more than 14% of all cancers and over 18% of all cancer deaths, however incidence varies by region. The highest rates are found in Eastern Asia; each year, over half a million new lung cancer cases are diagnosed in China, over 86,000 in Japan and over 9,000 in Taiwan.6 As lung cancer has a poor prognosis, it is important to choose the best treatment from the start.
The new LUX-Lung 3 and LUX-Lung 6 pooled safety analysis substantiates afatinib’s previously reported adverse events (AEs) and tolerability profile in Asian and non-Asian EGFR mutation positive NSCLC patients. The most common grade 3 side effects which occurred at a similar rate in both patient groups were diarrhoea, rash/acne and stomatitis (inflammation of the mouth).1 Furthermore, there was no difference in the afatinib pharmacokinetic exposure between the two patient populations.1 The data from LUX-Lung 3 and 6 previously showed that side effects were predictable, manageable and reversible and treatment discontinuation rates were low.2,3
“The new sub-analysis confirms the consistent safety profile of afatinib in Asian patients compared to non-Asian patients," commented Professor James Chih-Hsin Yang, director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan and lead investigator of the LUX-Lung 3 trial. “This further supports afatinib’s role as a valuable treatment option for patients with EGFR mutation positive lung cancer, which is three times more frequent in Asia than in Western countries."