The Lancet Oncology publishes Phase III data showing Giotrif^® (afatinib) significantly extended overall survival of lung cancer patients with the most common EGFR mutation over chemotherapy

Ingelheim, Germany, January 12, 2015 – 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.¹ 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.¹

“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.¹ For these patients, both studies individually demonstrated a significant reduction in the risk of death with first-line afatinib compared to chemotherapy.¹ 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).¹

The effect was not observed for patients with L858R mutations, whose survival did not significantly differ between treatment arms in each trial.1 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.^2,3

“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.^2,3 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.⁴

About afatinib
Afatinib (GIOTRIF^®/GILOTRIF^®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. In this indication, 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^®.

Approval of afatinib for the treatment of distinct types of EGFR mutation-positive NSCLC was based on the primary endpoint of progression-free survival from LUX-Lung 3, part of the LUX-Lung clinical trial programme. In the LUX-Lung 3 trial, afatinib significantly delayed tumour growth when compared to standard chemotherapy.² In addition, data from the LUX-Lung 3 and 6 trials demonstrated that afatinib is the first treatment to show an overall survival benefit (secondary endpoint) for patients with a specific type of EGFR mutation-positive NSCLC compared to chemotherapy.¹ A significant overall survival benefit was demonstrated in both individual trials for patients with the most common EGFR mutation (exon 19 deletion; Del19) compared to chemotherapy.¹

About the LUX-Lung 3 & 6 trials
 LUX-Lung 3 & 6 trials

About Boehringer Ingelheim in Oncology:  Boehringer Ingelheim in Oncology Backgrounder

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.