INGELHEIM, Germany. - Sunday, May 31st 2015 [ME NewsWire]

    In the Phase III LUX-Lung 8 trial, afatinib* significantly improved overall survival compared to erlotinib, reducing the risk of death by 19% in patients with advanced squamous cell carcinoma of the lung, previously treated with first-line chemotherapy
    Afatinib significantly delayed progression of lung cancer (primary endpoint) and improved control of cancer-related cough and shortness of breath compared to erlotinib
    The overall rate of severe adverse events (≥grade 3) was similar between both therapies, with differences observed in the incidence of certain side effects
    Global regulatory submissions are planned later this year to treat this patient population

(BUSINESS WIRE)-- Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib* and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4 vs 28.2%). The details of the OS analysis (abstract #8002 Oral presentation, Lung Cancer — Non-Small Cell Metastatic, Sunday 31 May, 8:00-11.00, N Hall B1) will be presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

The complete results from this study will be the basis for global regulatory submissions later this year. Afatinib is not approved for use in patients with SCC of the lung.

OS was the key secondary endpoint of this randomised Phase III head-to-head trial, and was analysed following positive results for the primary endpoint of progression-free survival (PFS) presented in 2014. The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19% in patients treated with afatinib compared with erlotinib. The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 vs 35.2%), shortness of breath (51.3 vs 44.1%) and overall well-being/quality of life (35.7 vs 28.3%) compared with erlotinib.

LUX-Lung 8 clinical trial investigator Professor Jean Charles Soria, Head Drug Development Department, Gustave Roussy Cancer Centre, Paris, France commented: “Squamous cell lung cancer is a difficult-to-treat disease with extensive comorbidities, and patients would benefit from more treatment options. The results of LUX-Lung 8 are very encouraging because they illustrate the clinical relevance of targeting ErbB receptors in this disease. International guidelines recognise erlotinib as a second-line treatment option for squamous cell carcinoma of the lung, and improved outcomes demonstrated with afatinib suggest this treatment could offer additional benefits for this patient population.”

The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 vs 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 vs 2.3/0.3%, grade 3 stomatitis: 4.1 vs 0.0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10.4 vs 5.9%). See abstract #8002 for full details.

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim, commented: “Following the approval of afatinib in more than 50 countries for the treatment of specific types of EGFR mutation-positive lung cancer and positive overall survival data in patients with the most common EGFR mutation, we are proud to present another piece of evidence for afatinib showing it can prolong survival of patients with squamous cell lung cancer. At Boehringer Ingelheim we are committed to research and development in areas of high unmet need such as this. It is our goal that afatinib can become a new treatment option for these cancer patients in the near future.”

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases. SCC, a type of lung cancer which develops in the cells lining the airways, represents approximately 30% of NSCLC cases. Treatment options are limited and SCC of the lung is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer.

LUX-Lung 8 was conducted across 23 countries and is the first prospective trial to compare two different tyrosine kinase inhibitors (TKIs) in patients with advanced SCC of the lung (n=795).

Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC (under the brand names: GIOTRIF® / GILOTRIF®). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.

*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. 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 other indications.

For notes to editors please visit https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/31_may_2015_oncology.html

Intended audiences:This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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