New efficacy and safety data adds to evidence supporting treatment with afatinib* (GIOTRIF) in Asian and non-Asian lung cancer patients

• New efficacy and safety analyses add to growing body of clinical data previously reported on afatinib compared to standard chemotherapies (pemetrexed/cisplatin and gemcitabine/cisplatin)
• New data confirms the irreversible ErbB Family Blocker, afatinib, has a manageable safety profile and is suitable for long-term treatment of EGFR mutation positive Asian and non-Asian lung cancer patients¹
• Afatinib has been approved in the USA, the EU, Mexico, Chile and in Asia in Taiwan for EGFR mutation positive non-small cell lung cancer (NSCLC) patients. Regulatory approvals are pending in other Asian countries

For NON-US media only

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 mutations⁴ and 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

• LUX-Lung 3: PFS 11.1 vs. 6.9 months afatinib vs. pemetrexed/cisplatin
• LUX-Lung 6: PFS 11.0 vs. 5.6 months afatinib vs. gemcitabine/cisplatin

(These are data from primary analyses based on independent review.)

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".

In a separate oral presentation, the largest data series to date of efficacy in patients with uncommon EGFR mutations pooled from three prospective clinical trials with afatinib are presented. The data shows that the activity of afatinib in certain types of rare EGFR mutations is in the same range as demonstrated for common EGFR mutations (deletion 19, L858R) patient.⁴

A subgroup analysis of LUX-Lung 3 demonstrated that afatinib was efficacious as a first line treatment option in patients with lung cancer harbouring common EGFR mutations who had metastatic brain disease.⁵

"Afatinib has clearly demonstrated its clinical benefit in our large, robust LUX-Lung clinical trial programme, which is now further supported by strong efficacy and safety data in important subpopulations," said Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The results of these analyses are very encouraging, and may make afatinib an important addition to the available treatment options for both Asian and non-Asian patients with lung cancer harbouring EGFR mutations."

In the EU, Taiwan, Mexico and Chile, afatinib is approved under the brand name GIOTRIF, and in the U.S. under the brand name GILOTRIFTM for use in patients with distinct types of NSCLC. Afatinib is under regulatory review by health authorities in Asia and other countries.

Notes to Editors

Please see here: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/27_october_2013_oncology.html

References

¹ Sequist LV, et al. Comparative safety profile of afatinib in Asian and non- Asian patients with EGFR mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC). Poster presented at World Congress on Lung Cancer 2013

² Yang JC, Shuler M, Yamamoto N, et al. LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. J Clin Oncol 2012;30(18,Suppl):abstract LBA 7500

³ Wu YL, Zhou C, Hu CP, et al. LUX-Lung 6: A randomized, open-label, Phase III study of afatinib (A) vs. gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts.) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung. (Abstract #8016) at American Society of Clinical Oncology, Chicago, June 2, 2013.

⁴ Yang J C-H, et al Activity of afatinib in uncommon epidermal growth factor receptor (EGFR) mutations: Findings from three trials of afatinib in EGFR mutation-positive lung cancer. Oral presentation at World Congress on Lung Cancer 2013.

⁵ Schuler M, et al. Efficacy of afatinib vs. chemotherapy in treatment-naïve patients with non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations with or without metastatic brain disease. Mini-Oral presentation at World Congress on Lung Cancer 2013.

⁶ Ferlay J et al. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010; 46 765-781.

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