INGELHEIM, Germany - Monday, January 12th 2015 [ME NewsWire]

    Results from two large trials independently showed a significant improvement in the secondary endpoint of overall survival for the subgroup of patients with the most common EGFR mutation (Del19)
    Patients with the Del19 mutation who received first-line afatinib compared to standard chemotherapy lived more than one year longer, achieving a 41% reduction in the risk of death
    Del19 is the most common EGFR mutation in lung cancer accounting for approximately 50% of all EGFR mutations
    LUX-Lung 3 and LUX-Lung 6 both met their primary endpoint of progression-free survival as afatinib significantly delayed tumour growth compared to standard chemotherapy regimens in patients with EGFR mutation-positive NSCLC

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(BUSINESS WIRE) - Boehringer Ingelheim today announced overall survival (OS) results were published in The Lancet Oncology from two independent Phase III clinical trials (LUX-Lung 3 and LUX-Lung 6) in epidermal growth factor receptor (EGFR) mutation-positive patients with metastatic non-small cell lung cancer (NSCLC). In each trial, patients whose tumours have the most common EGFR mutation (deletion in exon 19; Del19) lived more than one year longer when treated with first-line afatinib, an irreversible ErbB Family Blocker, compared to standard chemotherapy. Overall survival was a secondary endpoint. Afatinib is the first and only EGFR targeting agent to demonstrate an overall survival benefit compared to chemotherapy in the first-line treatment of NSCLC patients with EGFR mutations.

“The positive overall survival results seen with afatinib in these two trials are an encouraging development for NSCLC patients with Del19 mutated tumours. No other currently existing EGFR targeted therapy has demonstrated an overall survival benefit in lung cancer patients with any type of EGFR mutation,” said Professor James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan. “These data further add to the body of evidence for afatinib which has previously demonstrated improvements in progression-free survival, lung cancer symptom control and quality of life in both Del19 and L858R populations, compared to chemotherapy.”

Results from both trials showed similar overall survival in the afatinib and chemotherapy arms in the overall NSCLC EGFR mutation-positive population (LUX-Lung 3: median OS 28.2 vs 28.2 months; LUX-Lung 6: median OS 23.1 vs 23.5 months), however, a significant benefit was observed in patients with the Del19 mutation. For these patients, both studies individually demonstrated a significant reduction in the risk of death with first-line afatinib compared to chemotherapy. That translated into a survival benefit of more than a year (LUX-Lung 3: median OS 33.3 vs 21.1 months; LUX-Lung 6: median OS 31.4 vs 18.4 months).

The effect was not observed for patients with L858R mutations, whose survival did not significantly differ between treatment arms in each trial. Adverse events for afatinib in the LUX-Lung 3 and 6 trials were as expected with EGFR inhibition, and were predictable, manageable and reversible. Diarrhoea and rash/acne were the most frequently reported side effects with afatinib therapy.

“This is the first time a targeted agent in the first-line setting has shown an overall survival benefit for NSCLC patients with the Del19 EGFR mutation,” commented Professor Gerd Stehle, Vice President Medicine Therapeutic Area Oncology, Boehringer Ingelheim. “These data are an important scientific advancement as they clearly demonstrate that even within the EGFR mutation-positive patient group we are dealing with different molecular abnormalities that require a tailored treatment approach.”

LUX-Lung 3 (Global) and LUX-Lung 6 (Asian), two of the largest trials in this patient population, were similar in design with the exception of the platinum-based chemotherapy comparator regimen: pemetrexed/cisplatin in LUX-Lung 3 and gemcitabine/cisplatin in LUX-Lung 6‡. Both studies met the primary endpoint of progression-free survival for patients whose tumours have common EGFR mutations receiving first-line afatinib. In addition, more patients taking afatinib experienced an improvement in lung cancer-related symptoms (cough, shortness of breath, chest pain) and a significantly better quality of life, when compared with chemotherapy.

--Ends--

‡In LUX-Lung 6 gemcitabine and cisplatin were used as the comparator, as this combination is commonly used for the treatment of first-line NSCLC patients in China, the Republic of Korea and Thailand

*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 more information please visit http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/12_january_2015_oncology.html

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