EMA committee issues positive opinion for Boehringer’s lung cancer drug nintedanib

The approval is for nintedanib (Vargatef) in combination with docetaxel to treat adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.

The positive opinion from CHMP is based on the results of the LUME-Lung 1 clinical trial, which showed that compared to docetaxel alone, nintedanib plus docetaxel significantly extended the median overall survival from 10.3 to 12.6 months for patients with advanced adenocarcinoma, after first-line chemotherapy.

Adenocarcinoma is the most common type of lung cancer and these patients will experience disease progression after first-line chemotherapy and there is still a significant unmet need for new, effective second-line treatments for them who have a poor prognosis.

Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "Nintedanib, a triple angiokinase inhibitor, when added to docetaxel, provided adenocarcinoma patients with a median overall survival of over one year, a benefit which has not been achieved before."

In the randomised, double-blind LUME-Lung 1 Phase III trial a total of 1,314 patients, in Europe, Asia and South Africa, were given nintedanib 200mg twice daily plus docetaxel 75mg/m2 once a day, for three weeks or placebo plus docetaxel.

The trial compared nintedanib plus docetaxel in patients with locally advanced/metastatic NSCLC after first-line therapy, with placebo plus docetaxel.

The most common adverse events (AEs) observed in patients taking nintedanib plus docetaxel were gastro-intestinal side effects and reversible liver enzyme elevations which were manageable by either supportive treatment or dose reduction.

Image: Boehringer Ingelheim Center (BIC), the Corporate Headquarters Building in Ingelheim, Germany. Photo: courtesyofBoehringer Ingelheim GmbH.