Boehringer Ingelheim says it has submitted its first oncology compound, afatinib, to regulators in Europe.
The German firm has filed a marketing authorisation application to the European Medicines Agency for approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer. The drug has demonstrated "unprecedented efficacy versus chemotherapy" in the Phase III LUX-Lung 3 study, which provides the basis for the submission, the company says.
That trial compared afatinib to the best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous NSCLC 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 11.1 months without their tumour growing (progression-free survival) versus 6.9 months on the chemo combo.
More patients taking afatinib experienced an improvement in dyspnoea (shortness of breath), cough and chest pain and the drug also significantly delayed the deterioration of these symptoms compared to chemotherapy. A standard questionnaire also revealed that afatinib treatment translated into a better quality of life (eg 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 European Society for Medical Oncology congress in Vienna at the end of the month.
Klaus Dugi, head of medicine at Boehringer, said that "with so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies. He added that the positive clinical evidence for afatinib, "coupled with its novel mode of action, could make this an outstanding treatment option".
Boehringer has also initiated two head-to-head trials (LUX-Lung 7 and 8) comparing afatinib to the currently available tyrosine kinase inhibitors, AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib). The drug is currently also in Phase III in breast cancer and head and neck cancer.
