Boehringer Ingelheim files MAA with EMA for afatinib approval

Boehringer IngelheimSep 20 2012

Today, Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for approval of afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission.   

NSCLC comprises over 85% of the 391,000 new cases of lung cancer diagnosed annually in Europe, with adenocarcinoma being the most common type of NSCLC. Approximately 20-30% of all lung adenocarcinomas harbour EGFR mutations. Because of its poor prognosis, approximately 340,000 deaths each year in Europe are attributed to lung cancer, making it the most common cause of cancer death.   

"With so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies. Boehringer Ingelheim is committed to helping patients have access to afatinib as soon as possible," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The positive clinical evidence for afatinib, coupled with its novel mode of action, could make this an outstanding treatment option, providing much needed benefits for lung cancer patients."

The submission is based on the comprehensive LUX-Lung clinical trial programme. Data from the pivotal LUX-Lung 3 trial, comparing afatinib to the best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous NSCLC, demonstrated superiority in patients with stage IIIb or IV adenocarcinoma of the lung harbouring an EGFR mutation. Patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed / cisplatin). Furthermore, NSCLC patients with tumours harbouring the two most common EGFR mutations (del19 and L858R, accounting for 90% of all tumours with EGFR mutations) taking afatinib lived for well over a year without disease progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

The delay in disease progression for afatinib-treated patients was associated with an improvement of life-restricting lung cancer symptoms. More patients taking afatinib experienced an improvement in dyspnoea (shortness of breath), cough, and chest pain. Afatinib also significantly delayed the deterioration of these symptoms compared to chemotherapy.   

In addition, a standard questionnaire assessing the quality of life of lung cancer patients revealed that afatinib treatment translated into a better quality of life (e.g. at work and during household activities).

Additional data from the trial, including symptom improvement and health-related quality of life results, will be presented at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, 28 September - 2 October 2012:

While the LUX-Lung 3 trial demonstrated the superiority of afatinib in delaying disease progression versus best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous NSCLC, Boehringer Ingelheim is also exploring the broader potential of afatinib. The company has initiated two head-to-head trials (LUX-Lung 7 and 8) directly comparing afatinib to the currently available tyrosine kinase inhibitors (TKIs), gefitinib and erlotinib, respectively. Both trials are actively recruiting patients.