New Subgroup Analysis Shows Asian Non-Small Cell Lung Cancer Patients with Most Common EGFR Mutation (del19) Lived Significantly Longer With First-Line GIOTRIF® (afatinib*) Compared to Chemotherapy

* Pre-specified subgroup-analysis from Phase III LUX-Lung 3 trial shows afatinib significantly extended overall survival in Asian NSCLC patients** with the most common EGFR mutation (del19) compared to standard chemotherapy (secondary endpoint)1

* Afatinib is the first treatment to demonstrate a significant overall survival benefit for NSCLC patients with a specific type of EGFR mutation, independent of Asian or Caucasian descent1,2

* LUX-Lung 3 also met its primary endpoint of progression-free survival in the overall study population3

For Media In Asian Countries Only For Whom The Data Is Relevant (For media outside UK, US and Canada only)

Ingelheim, Germany (Antara Bali) - Boehringer Ingelheim today announced data from a pre-specified subgroup-analysis of the pivotal Phase III LUX-Lung 3 trial which demonstrated that Asian non-small cell lung cancer (NSCLC) patients with the most common type of EGFR mutation (exon 19 deletion; del19), lived significantly longer after receiving first-line treatment with afatinib compared to chemotherapy (33.3 vs 22.9 months, respectively).1 This equated to a significant 43% reduction in the risk of death.1 The data were presented today at the 2014 IASLC Asia Pacific Lung Cancer Conference (APLCC), in Kuala Lumpur.

Overall survival results from this pre-specified Asian subgroup-analysis are consistent with the overall del19 population in LUX-Lung 3,1 and with the previously reported Asian Phase III LUX-Lung 6 trial, in which patients with the del19 mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy.2 No significant difference in overall survival was seen for Asian patients with the L858R mutation in the LUX-Lung 3 and LUX-Lung 6 subgroup-analyses, respectively.1

Professor Yi-Long Wu from the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China and principal investigator of the LUX-Lung 6 trial commented: “Afatinib is the first treatment to demonstrate a significant overall survival benefit for NSCLC patients with the del19 mutation, the most common EGFR mutation. More than half of the world’s lung cancer cases occur in Asia. Therefore, EGFR testing for NSCLC patients is important in order to identify the patients eligible for targeted therapy."

Demonstrating an overall survival benefit is a key advancement for NSCLC treatments and an important outcome for patients. In Asia, more than 900,000 new cases of lung cancer are diagnosed each year.4 The prevalence of EGFR mutations in Asian NSCLC patients is approximately 40%,5 and del19 accounts for 50% of these mutations,3,6 representing a substantial group of lung cancer patients who could potentially benefit from treatment with afatinib.

Previously reported data from the LUX-Lung 3 trial showed afatinib provided further benefits to NSCLC patients with common EGFR mutations (del19 and L858R), which account for 90% of all EGFR mutations.3 Patients with common EGFR mutations taking afatinib lived for over a year without their tumour growing (progression free survival; PFS of 13.6 months; primary endpoint) versus just over half a year (PFS of 6.9 months) for chemotherapy.3 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.7

Furthermore, in a combined exploratory analysis of the LUX-Lung 3 and LUX-Lung 6 trials, afatinib prolonged overall survival (secondary endpoint) of patients with common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 compared to 24.3 months, respectively).2

Adverse events for afatinib in the LUX-Lung 3 and 6 trials were as expected with EGFR inhibition, and were predictable, manageable and reversible.3,6 Diarrhoea and rash/acne were the most frequently reported side effects with afatinib therapy.3,6

Professor James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan, and principal investigator of the LUX-Lung 3 trial commented: “Overall survival benefit in trials involving advanced lung cancer patients has rarely been observed up until now. Data from the LUX-Lung 3 and LUX-Lung 6 trials, individually demonstrating an overall survival benefit of more than 12 months in the subgroup of NSCLC patients with the del19 mutation taking afatinib versus chemotherapy, is very encouraging. These studies suggest that various EGFR mutations should be studied or treated differently in the future.”

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*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications. Registration conditions differ internationally, please refer to locally approved prescribing information.

**The following Asian countries were represented in the LUX-Lung 3 trial: Hong Kong, Japan, Korea, Malaysia, Philippines, Taiwan and Thailand.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/07_november_2014oncology.html

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(Business Wire/ADT)