INGELHEIM, Germany. - Friday, September 26th 2014 [ME NewsWire]

• Nintedanib*, when added to docetaxel, is the first lung cancer treatment to have provided over one year overall survival for patients with advanced adenocarcinoma, after first-line chemotherapy

• Adenocarcinoma is the most common type of lung cancer and nintedanib* has demonstrated the first advancement in overall survival benefit for this patient population in over a decade

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Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of nintedanib* (suggested brand name Vargatef®) in combination with docetaxel for the treatment of 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 accounts for nearly half of all NSCLC cases. The majority of patients with advanced adenocarcinoma will experience disease progression after first-line chemotherapy and there is still a significant unmet need for new, effective second-line treatments for these patients who have a poor prognosis.

“We are delighted to receive this positive opinion from the CHMP”, said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “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.”

The CHMP opinion is based on the outcomes of the LUME-Lung 1 clinical trial. The results 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 (p=0.0359; HR: 0.83).

The additional benefit nintedanib* provided to adenocarcinoma patients was achieved without nintedanib* further impacting their quality of life. Most common adverse events (AEs) for 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.

“Patients with advanced adenocarcinoma NSCLC after first-line chemotherapy typically have a very poor prognosis. Therefore, providing an extension of overall survival while maintaining quality of life remains the ultimate goal”, commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. “Nintedanib has shown promise in achieving this by prolonging the overall survival beyond the one year barrier in second-line adenocarcinoma NSCLC patients.”

Nintedanib* is the second compound in the Boehringer Ingelheim oncology portfolio after afatinib** (GIOTRIF®/GILOTRIF®) which is approved to treat lung cancer patients with distinct types of NSCLC.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/26_september_2014_oncology.html

*Nintedanib is an investigational compound and is not yet approved. Its safety and efficacy have not yet been fully established.

**Afatinib (GIOTRIF® / GILOTRIF®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. In this indication, afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF®. It is under regulatory review in other countries. Afatinib is not approved in other indications.

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