Superiority of afatinib* over comparator chemotherapy for patients with EGFR mutation-positive advanced lung cancer is reinforced by second Phase III study

Results from LUX-Lung 6, together with previously reported LUX-Lung 3 data, substantiate the efficacy and safety of afatinib* in lung cancer patients with EGFR mutations when compared with standard chemotherapies

Data from Boehringer Ingelheim's LUX-Lung 6 trial, presented at the official American Society of Clinical Oncology (ASCO) Annual Conference, demonstrate that patients treated with the novel, investigational compound afatinib* lived for almost one year before their tumour started to grow again, compared to less than half a year for those on standard chemotherapy (gemcitabine/cisplatin). Tumour assessment was based on independent review of the data showing progression-free survival (PFS) of 11.0 months for afatinib* and PFS of 5.6 months for chemotherapy.¹ In addition, 47% of afatinib*-treated patients were alive and progression-free after one year of treatment compared to only 2% on chemotherapy.

LUX-Lung 6 is the second Phase III trial after LUX-Lung 3 to show superiority of afatinib* over standard chemotherapies² in patients with EGFR (ErbB1) mutation-positive non-small cell lung cancer (NSCLC). The consistent results in two large prospective trials in this patient population substantiate the robust efficacy of afatinib*.^1,3

"LUX-Lung 6 and LUX-Lung 3 together represent the largest clinical trial programme in EGFR mutation-positive NSCLC patients," said Professor James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan. "The results of both trials have shown us that afatinib* could offer lung cancer patients with EGFR mutations a significant delay in tumour growth, and a better quality of life, compared to current standard of care chemotherapies."

The delay in tumour growth compares well in both registration studies, underlining the robustness of the data.

• LUX-Lung 3: PFS 11.1 vs. 6.9 months afatinib* vs. pemetrexed/cisplatin³
• LUX-Lung 6: PFS 11.0 vs. 5.6 months afatinib* vs. gemcitabine/cisplatin¹

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

Consistent with LUX-Lung 3, afatinib* treatment led to significant and sustained tumour shrinkage compared to chemotherapy (gemcitabine/ cisplatin) in LUX-Lung 6. Specifically, in approximately two thirds of patients (66.9%) taking afatinib*, the tumour shrank (objective response) significantly in size compared to 23% in the chemotherapy arm (gemcitabine/cisplatin), by independent review.¹ Tumour shrinkage with afatinib* translated into improvements in life-restricting, disease-related symptoms such as cough, pain and shortness of breath (dyspnoea) as measured by standard lung cancer questionnaires.⁴

In addition, afatinib*-treated patients also reported to have a significantly better quality of life (e.g. at work and during household activities) than those on gemcitabine/cisplatin (as measured by standard lung cancer questionnaires).⁴ These quality of life results are also consistent with data from the LUX-Lung programme, including the LUX-Lung 3 clinical trial results presented at last year's ASCO.

"We are extremely encouraged by the clinical evidence base for afatinib* so far, and the results of the LUX-Lung 6 trial reaffirm our belief in this compound as a highly effective first-line treatment option for patients with lung cancer harbouring EGFR mutations," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The LUX-Lung clinical trials form part of our extensive oncology development programme aimed at improving the lives of people affected by cancer, through the advance of innovative treatments such as afatinib*."

The most common Grade 3 adverse events (AEs) associated with afatinib* in LUX-Lung 6 were rash (14.2%), diarrhoea (5.4%) and stomatitis/mucositis (inflammation of the mouth and throat) (5.4%).¹ These side effects are as expected with EGFR inhibition, consistent with previous studies, and were predictable, manageable and reversible. The most common AEs associated with chemotherapy were neutropenia (an abnormally low level of neutrophils, a type of white blood cell) (17.7%), vomiting (15.9%) and leukopenia (a decrease in the number of white blood cells) (13.3%). The discontinuation rate due to AEs related to treatment was 5.9% of patients on the afatinib* arm and 39.8% of patients on the chemotherapy arm. Importantly, only 2% of patients on afatinib* decided to discontinue due to rash and none for diarrhoea.¹

NSCLC comprises over 85% of the 391,000 new cases of lung cancer diagnosed annually in Europe. Because of its poor prognosis, approximately 340,000 deaths each year in Europe are attributed to lung cancer, making it the most common cause of cancer death.^5,6 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.⁷ Early testing for tumour EGFR mutation status of lung cancer patients is critical in improving patient outcomes. Between 10-15% of Caucasian and 40% of Asian NSCLC patients have tumours harbouring EGFR mutations.⁸

Afatinib* is an irreversible ErbB Family Blocker, thus it differs from currently available targeted therapies in that it irreversibly and completely inhibits ErbB receptor signal transduction, blocking the key pathways that help tumour cells grow, migrate and metabolise.⁹ This novel mode of action may lead to a distinct therapeutic benefit¹⁰ and is further being investigated in the comprehensive LUX-Lung trial programme.

For Notes to Editors and References please visit:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/01_june_2013_oncology.html

For more information please visit

www.boehringer-ingelheim.com and www.newshome.com.

*Afatinib is an investigational compound and is not yet approved. Its safety and efficacy have not yet been fully established.

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Reinhard Malin
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