Boehringer Ingelheim’s move into cancer treatment reached another milestone this week with the filing of its lung cancer candidate nintedanib in the EU.
Nintedanib has been submitted for approval as a second-line treatment alongside docetaxel for treating locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) in patients whose tumours are adenocarcinomas, derived from the cells that produce mucus in the lining of the airways.
Adenocarcinoma is the most common type of lung cancer, according to the company, and more than two-thirds of patients are diagnosed at a late stage when curative treatment is no longer feasible.
If approved, nintedanib will be Boehringer’s second NSCLC treatment in Europe after irreversible ErbB blocker Giotrif (afatinib), which was approved by the European Medicines Agency (EMA) last month and by the US Food and Drug Administration (FDA) as Gilotrif in July.
Having two drugs may help Boehringer wrestle market share from current NSCLC treatments such as Roche’s Avastin (bevacizumab) and Tarceva (erlotinib; co-marketed with Astellas) and AstraZeneca’s Iressa (gefitinib).
Boehringer claims nintedanib is the first lung cancer treatment that has extended patient survival beyond one year in a broad population of adenocarcinoma patients after initial chemotherapy has failed.
The EU filing is based on the results of the 1,300-patient LUME-Lung 1 trial which compared nintedanib plus docetaxel to docetaxel and placebo.
The results showed that the patients in the placebo arm had an increase in median overall survival of 10.3 months after patients failed first-line chemotherapy compared to an increase of 12.6 months with Boehringer’s drug.
“The results demonstrated that patients with adenocarcinoma who have failed initial treatment with chemotherapy received on average a 20 per cent extension of overall survival,” said the company.
Nintedanib is described as a triple angiokinase inhibitor, targeting receptors for three growth factors – vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and fibroblast growth factor (FGF) – that are thought to be involved in the formation of blood vessels in tumours.
In addition to NSCLC the drug is also being tested for ovarian cancer, hepatic cell carcinoma, renal cell carcinoma and colorectal cancer.
Boehringer’s late-stage cancer portfolio also includes polo-like kinase 1 (Plk1) inhibitor volasertib, which is being developed to treat acute myeloid leukaemia.