The European Commission has granted EU marketing authorisation for Vargatef ( Nintedanib ). Vargatef in combination with Docetaxel ( Taxotere ) is indicated for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer ( NSCLC ) of adenocarcinoma tumour histology, after first-line chemotherapy.
Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most patients will experience disease progression during or after first-line chemotherapy and there is a significant unmet need for new, effective second-line treatments.
The approval of Nintedanib, a triple angiokinase inhibitor, is based on the outcomes of the LUME-Lung 1 clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy.
Data from the study demonstrated that compared to Docetaxel alone, Nintedanib when added to Docetaxel significantly extended median overall survival from 10.3 to 12.6 months ( p=0.0359; HR=0.83 ) for patients with adenocarcinoma, with a quarter of patients surviving for two years or more ( survival at 24 months: Nintedanib plus Docetaxel, 25.7% of patients versus placebo plus Docetaxel, 19.1% of patients, p=0.0359; HR=0.83 ).
Nintedanib has shown a manageable adverse event profile without further compromising patients’ overall health-related quality of life.
Adding Nintedanib to Docetaxel did not significantly increase discontinuation rates, compared to Docetaxel alone.
Nintedanib is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors ( VEGFR ), platelet-derived growth factor receptors ( PDGFR ) and fibroblast growth factor receptors ( FGFR ) signalling pathways.
Growing evidence shows that these three different angiokinase receptors play an important role not only in angiogenesis but also in tumour growth and metastasis. ( Xagena )
Source: Boehringer Ingelheim, 2014