Boehringer submits an MAA for Vargatef in NSCLC

Boehringer Ingelheim has submitted a Marketing Authorisation Application to the EMA for the approval of Vargatef (nintedanib), in combination with docetaxel, for the treatment of patients with locally advanced metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy. The application is based on the international double-blind Phase III LUME-Lung 1 trial which was the first trial to show a survival benefit of an add-on treatment in a broad second line adenocarcinoma patient population versus an active comparator (standard-of-care/chemotherapy).

In this trial in advanced NSCLC patients the combination of nintedanib plus docetaxel demonstrated a statistically significant prolonged progression-free survival (PFS) versus placebo (3.4 vs. 2.7 months respectively) 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). Patients with adenocarcinoma who failed initial chemotherapy received on average a 20% extension of overall survival.