• Positive CHMP opinion follows FDA approval for Boehringer Ingelheim’s frontrunner oncology compound
• The largest global Phase III registration trial, LUX-Lung 3, demonstrated that patients with EGFR mutation positive lung cancer benefited from afatinib treatment versus standard chemotherapy

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for afatinib – which has been submitted under the European Union brand name GIOTRIF^®*. Afatinib is the first irreversible ErbB Family Blocker for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

“Boehringer Ingelheim welcomes the decision by the CHMP which follows the recent FDA approval of afatinib. We look forward to making afatinib available soon to patients with EGFR mutation positive lung cancer in Europe,” said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Afatinib irreversibly blocks EGFR and other relevant members of the ErbB Family and has demonstrated a meaningful therapeutic benefit in clinical trials.”

The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.¹ In clinical trials, afatinib has been shown to offer patients with this type of lung cancer a significant delay in tumour progression, coupled with improvements in their lung cancer related symptoms and quality of life.^2,3 Therefore, testing for mutations in EGFR is a crucial step in the treatment-decision pathway, and is strongly recommended by many international oncology organisations. This enables healthcare professionals to make informed treatment decisions and patients to receive the right targeted therapy from the start.

“Targeted therapies offer a personalised approach to lung cancer treatment, from which patients can hugely benefit”, commented Dr. Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial. “Today’s recommendation for approval of afatinib by the CHMP brings us even closer to providing patients in Europe with advanced NSCLC, the prospect of a targeted treatment option, which has demonstrated consistent and superior efficacy compared with standard chemotherapy across large scale clinical trials.”

The CHMP’s positive opinion for afatinib is based on data from the pivotal LUX-Lung 3 trial, the largest global Phase III trial in patients with EGFR mutation positive lung cancer, comparing afatinib to chemotherapy with pemetrexed/cisplatin. Data from LUX-Lung 3 has shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. Of note, NSCLC patients with tumours harbouring the two most common EGFR mutations (del19 or L858R, accounting for 90% of all EGFR mutations) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.²

The delay in disease progression for afatinib demonstrated in clinical trials was associated with better control of life-restricting disease-related symptoms. More patients taking afatinib experienced improvement of symptoms such as dyspnoea (shortness of breath), cough and chest pain, as measured by standard lung cancer questionnaires. Afatinib also delayed the worsening of these symptoms.³

There was a low discontinuation rate associated with treatment-related adverse events in the LUX-Lung 3 trial (8% discontinuation rate for afatinib; 12% for chemotherapy). The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). One percent of patients in the afatinib arm discontinued due to drug-related diarrhoea.² The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%).

Afatinib is approved in the U.S. under the U.S. brand name GILOTRIF™ and has been submitted to regulatory bodies in Asia and worldwide for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. Regulatory reviews by health authorities in the EU, Asia and other countries are ongoing.

Notes to Editors

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/26_july_2013_oncology.html

^* Afatinib’s anticipated brand name for the European Union is GIOTRIF®. In the U.S., afatinib is approved under the U.S. brand name GILOTRIF™. Regulatory reviews by health authorities in the EU, Asia and other countries are ongoing.

References

¹ Jang TW et al. 2009. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March; 24(1), pp.48–54.

² Yang JC, Shuler M, Yamamoto N, et al. LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. J Clin Oncol 2012;30(18,Suppl):abstract LBA 7500.

³ Sequist LV et al. LUX-Lung 3: Symptom and health-related quality of life results from a randomized phase III study in 1st-line advanced NSCLC patients harbouring EGFR mutations. ESMO 2012 Congress. Abstract no: 1229PD.

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