INGELHEIM, Germany I November 27, 2014 I Today Boehringer Ingelheim announced that the European Commission has granted EU marketing authorisation for Vargatef® (nintedanib*), valid for the 28 countries within the EU. Vargatef® in combination with docetaxel 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.
“The approval of nintedanib offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting,” commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany and lead investigator of the LUME-Lung 1 trial. “The clinical data has shown that patients receiving nintedanib plus docetaxel experienced over one year overall survival with no further compromise to their quality of life, compared to docetaxel alone.”
Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage.2 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.3
“We are delighted by the European Commission’s decision to approve Vargatef® in the EU and feel extremely proud that our long standing commitment to oncology research and development has brought a new option to lung cancer patients with this specific type of disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The approval of Vargatef® expands our oncology portfolio, following last year’s approval of GIOTRIF® (afatinib) for another specific type of lung cancer. In the idiopathic pulmonary fibrosis indication, nintedanib has recently been approved by the U.S. FDA.”
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.1 Data from the study, published in Lancet Oncology (Feb 2014), 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 vs. placebo plus docetaxel, 19.1% of patients, p=0.0359; HR: 0.83).1
Nintedanib* demonstrated 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.1
Nintedanib* is an oral, twice-daily treatment and is the second approved compound in the Boehringer Ingelheim oncology portfolio. GIOTRIF® (afatinib‡) was the first oncology drug from the portfolio to be approved to treat non-small cell lung cancer patients with distinct types of EGFR-mutation positive NSCLC.
About Vargatef® (nintedanib*)
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 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 tumours including Phase III studies in advanced NSCLC1, 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.
In the EU, nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF) has recently received a positive CHMP opinion. The U.S. Food and Drug Administration (FDA) has approved nintedanib* capsules under the brand name OFEV® for oral use for the treatment of IPF.
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
Boehringer Ingelheim in Oncology
http://newscentre.boehringer-ingelheim.com/education_hub1/oncology.html
Boehringer Ingelheim
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
*Nintedanib is approved in the EU under the brand name Vargatef® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.
‡A fatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.
References
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 [Last Accessed: November 2014].
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 [Last Accessed: November 2014].
9 Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. Available at: http://clinicaltrials.gov/ct2/show/NCT01024920?term=nintedanib+renal&rank=1 [Last Accessed: November 2014].
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 [Last Accessed: November 2014].
SOURCE: Boehringer Ingelheim
