Nintedanib* receives positive CHMP opinion for second-line treatment of patients with adenocarcinoma of the lung
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 chemotherapy1
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 decade1
Ingelheim, Germany, 26 September 2014 – 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.2 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.1,2
"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).1
The additional benefit nintedanib* provided to adenocarcinoma patients was achieved without nintedanib* further impacting their quality of life.1 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.1
"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.
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.3 Growing scientific evidence shows that these three different angiokinase receptors play an important role not only in angiogenesis but also in tumour growth and metastasis.4,5
Nintedanib* is currently being investigated in patients with various solid tumors including Phase III studies in advanced NSCLC 1, colon cancer (colorectal cancer refractory to standard treatment)6 and ovarian cancer7, and also in Phase II studies in mesothelioma8, kidney cancer (renal cell carcinoma)9 and liver cancer (hepatic cell carcinoma)10.
Another EU marketing authorisation application (MAA), as well as a U.S. New Drug Application (NDA), has also been submitted for nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF). 11
About the LUME-Lung 1 trial
LUME-Lung 1 is a randomised, double-blind, Phase III study comparing nintedanib* plus docetaxel in patients with locally advanced/metastatic NSCLC after first-line therapy, with placebo plus docetaxel.1 The study included 1,314 patients, in Europe, Asia and South Africa, randomised to receive nintedanib* 200mg twice daily plus docetaxel 75mg/m2 once a day, for 3 weeks (n=655) or placebo plus docetaxel (n=659).1
Adenocarcinoma is the most common type of lung cancer and more than two–thirds of patients are diagnosed at an advanced stage.1 Most patients will experience disease progression after first-line chemotherapy and there is still a significant unmet need for new effective second-line treatments for patients with advanced adenocarcinoma.1,2
Boehringer Ingelheim in Oncology
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.
For more information please visit www.boehringer-ingelheim.com
1 Reck M, Kaiser R, Mellemgaard A et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol 2014;15:143–55.
2 Howlader N,et al. SEER Cancer Statistics Review, 1975-2011, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2011/, based on November 2013 SEER data submission, posted to the SEER website, April 2014.
3 Hilberg F, Roth GJ, Krssak M, et al. BIBF1120: triple angiokinase inhibitor with sustained receptor blockade and good anti-tumor efficacy. Cancer Res 2008;68: 4774-82.
4 Folkman N. Clinical applications of research on angiogenesis. N Engl J Med 1995;333: 1757-63.
5 Bousquet C, Lamande N, Brand M, et al. Suppression of angiogenesis, tumor growth, and metastasis by adenovirus-mediated gene transfer of human angiotensinogen. Mol Ther 2006;14:175-82.
6 Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02149108?term=nintedanib+colorectal&rank=2
7 du Bois A, et al. AGO-OVAR 12/LUME-Ovar. Presented at ESGO 2013
8 Nintedanib (BIBF 1120) in Mesothelioma. Available at: http://clinicaltrials.gov/ct2/show/NCT01907100?term=nintedanib+mesothelioma&rank=1
9 Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. Available at: http://clinicaltrials.gov/ct2/show/NCT01024920?term=nintedanib+renal&rank=1
10 Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma. Available at: clinicaltrials.gov/ct2/show/NCT01004003?term=nintedanib+hepatic+cancer&rank=2
11 Richeldi L, du Bois RM, Raghu G et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014; 370:2071-2082.
*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.
Media & PR
Binger Strasse 173
55216 Ingelheim am Rhein
Phone +49/6132/77 2091
Fax +49/6132/77 6601