A few weeks after getting approval for Giotrif, Boehringer Ingelheim has filed nintedanib, another lung cancer compound, with regulators in Europe.
The German group has submitted a marketing authorisation application to the European Medicines Agency for the oral triple angiokinase inhibitor in combination with docetaxel. Specifically, it is seeking approval for the drug as a treatment of patients with advanced non-small cell lung cancer of adenocarcinoma histology after first line chemotherapy.
The filing is based on the Phase III LUME-Lung 1 trial, which was the first study to show a survival benefit of an add-on treatment in a broad-second line adenocarcinoma patient population versus standard-of-care/chemotherapy. The combination of nintedanib plus docetaxel demonstrated statistically significant prolonged progression-free survival versus placebo (3.4 versus 2.7 months) regardless of tumour histology, reducing the risk of renewed tumour growth by 21%.
Overall survival was significantly prolonged in adenocarcinoma patients treated with nintedanib plus docetaxel versus placebo plus docetaxel (12.6 vs. 10.3 months respectively). The results also demonstrated that patients with adenocarcinoma who have failed initial treatment with chemotherapy received on average a 20% extension of overall survival.
Adenocarcinoma is the most common type of lung cancer and more than two-thirds of patients are diagnosed at a late stage when curative treatment is no longer feasible.
If all goes well, nintedanib will be Boehringer’s second NSCLC drug to be available in Europe. Giotrif (afatinib) was approved in Europe at the end of September by the European Commission for patients whose tumours express specific types of epidermal growth factor receptor (EGFR) gene mutations.
