BRACKNELL, England--(BUSINESS WIRE)--For UK consumer media only
Boehringer Ingelheim Limited today announced that following a review by the National Institute for Health and Care Excellence (NICE) Vargatef® (nintedanib) in combination with docetaxel within its marketing authorisation has been recommended as a treatment option within the National Health Service (NHS), for patients with a common type of advanced lung cancer - non-small cell lung cancer (NSCLC) of adenocarcinoma histology - who have received chemotherapy as their first treatment and that chemotherapy has stopped working.1 This will come as a welcome decision to these patients, as they have limited treatment options available to them.
Nintedanib belongs to a class of drugs known as angiogenesis inhibitors, which prevent nutrients and oxygen from reaching the tumour, by interfering with its blood supply. Nintedanib is the first angiogenesis inhibitor licensed, in combination with docetaxel, for the treatment of patients with advanced NSCLC of adenocarcinoma histology, who have been previously treated with one chemotherapy regime. 2,3
Zinta Krumins, Country Manager, Boehringer Ingelheim UK and Ireland Ltd said “We are extremely pleased that Vargatef® has been recommended especially as the options in this setting are so limited. This will come as welcome news to patients, their families and carers”.
Vargatef® (nintedanib) was granted European marketing authorisation on 21st November 2014 based on the international, placebo controlled Phase III LUME-Lung I trial which compared nintedanib plus docetaxel (a chemotherapy that is the standard of care in this treatment setting), to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of first-line therapy.3
The median overall survival (or the median time taken until end of life occurs) which was a key secondary endpoint in the LUME-Lung 1 study, was significantly longer in those patients of adenocarcinoma histology treated with nintedanib plus docetaxel compared to placebo plus docetaxel (median 12.6 months versus 10.3 months respectively, p=0.0359) [2.3 month difference].3
There was no overall impact on global health or quality of life with the addition of nintedanib to docetaxel in patients with adenocarcinoma histology.4 The most common adverse events were gastrointestinal side effects and liver enzyme elevations which were managed with supportive treatment and / or dose reductions3.
ENDS
Notes to Editors
About the LUME-Lung 1 trial
LUME-Lung 1 is a randomised, double-blind, Phase III study comparing nintedanib plus docetaxel to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of first-line therapy. The study included 1,314 patients in Europe, Asia and South Africa, randomised to receive oral nintedanib 200 mg twice daily on days 2-21, plus docetaxel 75 mg/m2 on day 1 of each 3-week cycle (n=655) or matching placebo plus docetaxel (n=659). Patients were treated until disease progression or intolerable adverse events3.
About nintedanib
Nintedanib is an oral triple angiokinase inhibitor that targets three growth factor receptor classes simultaneously: vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta), and fibroblast growth factor receptors (FGFR 1-3).5 All three receptor classes have a key role in the formation and maintenance of new blood vessels (angiogenesis); their blockade may help to inhibit angiogenesis, which plays a critical role in tumour growth and spread.6,7
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.co.uk.
References
1 NICE Final Appraisal Determination. Nintedanib for previously treated locally advanced, metastatic, or locally recurrent non-small cell lung cancer. May 2015
2 Vargatef® 100 mg, 150 mg soft capsules. Summary of Product Characteristics 2015.
100 mg https://www.medicines.org.uk/emc/medicine/29790 last accessed April 2015
150 mg https://www.medicines.org.uk/emc/medicine/29791 last accessed April 2015
3 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.
4 Novello S, Kaiser R, Mellemgaard A et al. Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer. European Journal of Cancer 2014. Epub ahead of print.
5 Hillberg F, Roth GJ, Krssak M et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good anti-tumour efficacy. Cancer Res 2008; 68: 4774-82
6 Folkman N. Clinical applications of research on angiogenesis. N Engl J Med 1995; 333; 1757-63.
7 Bousquet C, Lamande N, Brand M et al. Suppression of angiogenesis, tumour growth and metastatis by adenovirus-mediated gene transfer of human angiotensinogen. Mol Ther 2006; 14: 175-82.
